Medical Devices

Enclosure 2 to Appendix L of In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions

  1. Is there a legally marketed predicate device?

    YES   _____

    NO    _____

  2. Does the new device have the same intended use or indications for use of the predicate device?

    YES   _____

    NO    _____

  3. If the answer to question #2 is NO, do differences in intended use or indications for use between the new device and the predicate alter the intended therapeutic/diagnostic effect of the new device (consider impact on safety and effectiveness)?

    YES   _____

    NO    _____

  4. If the new device has the same intended use or indications for use as the predicate device, or if it does not, and if the differences do not alter the intended therapeutic/diagnostic effect,

    • Is it a new analyte?     YES   _____     NO   _____

    • Does it utilize novel matrix?     YES   _____     NO   _____

    • Does it utilize novel methodology?     YES   _____     NO   _____

    • Does it utilize novel technology?     YES   _____     NO   _____
  5. If the answer to one of the elements of question #4 is YES, could the change raise new issues of safety and effectiveness?

    YES   _____

    NO    _____

  6. If the answer to all elements of question #4 is NO, is the device intended to be used in:

    • Traditional Clinical laboratories?     YES   _____     NO   _____

    • Point of Care?     YES   _____     NO   _____

    • Physician Office Laboratory?     YES   _____     NO   _____

    • Over-the-counter?     YES   _____     NO   _____
  7. If the device is intended for over-the-counter-use, is the use of the test results well established in lay hands?

    YES   _____

    NO    _____

  8. If the device is intended for commercial clinical laboratories, does FDA have knowledge/experience with similar devices?

    YES   _____

    NO    _____

  9. If the FDA has knowledge/experience with similar devices, is the use of the device in clinical practice the major determinant in diagnosis or treatment?

    YES   _____

    NO    _____


RATIONALE FOR THE DCLD DECISION CHART

The decision chart is based on an assessment of risk to the patient associated with the use of the device. If the risk of device use is low and predictable, a low level of premarket review may be required for clearance. If the risk is high or unknown, more data is required and a more intense review of the data is necessary.

The first four criteria in the decision chart deal with WHAT is the device, i.e., what it measures, what matrix it uses, what methodology it utilizes, and what technology it employs, and with WHY is the device indicated for use in the clinical setting. If we do not have a clear understanding of what is the device, its clinical relevance and its role in clinical practice, the risk to the patient associated with the use of the device is unknown.

Next, the DCLD decision chart deals with WHO will use the device. The risk to the patient associated with the use of the device will be directly related to the amount of clinical laboratory training and experience of the person performing the test. As user training and experience increases, device risk tends to become lower and more predictable allowing for a lower level of premarket review. Special attention is needed for products intended for use in lay hands; in these settings premarket review may require evaluation of both technical use of the product and use and interpretation of the information generated from over-the -counter testing.

The repeated exposure of FDA reviewers to a specific type of device will lead to a better understanding of the risks to the patient associated with the use of the device. The better understanding of risks will result from the larger number of known studies available with a particular device and from the higher probability of learning about possible device failures through the medical device adverse event reporting program.

Finally, of importance is HOW will the device be used in clinical practice. This question takes into account the importance of the results of the test in patient management. IVD devices that are a major determinant of diagnosis, treatment, or prognosis are associated with high risk to the patient from using the device and require a more stringent level of data review.

Several workshop panelists commented that this item should be placed earlier on in the decision chart. In reality, what impacts on the tier decision is not where in the chart this element is placed, but how major determinant is defiend. If major determinant is defined as the test that is the major determinant or the sole determinant of diagnosis more IVD products will be placed in tier 1 review. If we define major determinant as proposed, i.e., a major deteminant in diagnosis, therapy, or prognosis, then fewer IVD products will receive tier 1 review.


IVD DEVICES SUBJECT TO TIER 1 REVIEW

PanelProduct CodeCommon NameClassRegulation
IMDCFALBUMIN, ANTIGEN, ANTISERUM, CONTROLII866.5040
IMJZJPREALBUMIN, ANTIGEN, ANTISERUM, CONTROLI866.5060
IMDDECARBONIC ANHYDRASE C, ANTIGEN, ANTISERUM, CONTROLI866.5200
IMDDHCARBONIC ANHYDRASE B, ANTIGEN, ANTISERUM, CONTROLI866.5200
IMKTKREAGENT, IMMUNOASSAY, CARBONIC ANHYDRASE B AND CI866.5200
IMDCKC-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROLII866.5270
IMJZHFACTOR B, ANTIGEN, ANTISERUM, CONTROLII866.5320
IMDBFFERRITIN, ANTIGEN, ANTISERUM, CONTROLII866.5340
IMDCOALPHA-GLOBULIN, ANTIGEN, ANTISERUM, CONTROLI866.5400
IMDAWALPHA-2-AP-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROLI866.5425
IMDBCALPHA 2, 2N-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROLI866.5425
IMDEFALPHA-2-HS-GLYCOPROTEIN, ANTIGEN, ANTISERUM, CONTROLI866.5425
IMDEJALPHA-2-GLYCOPROTEINS, ANTIGEN, ANTISERUM, CONTROLI866.5425
IMDDNBETA-2-GLYCOPROTEIN I, ANTIGEN, ANTISERUM, CONTROLI866.5430
IMDDKBETA-2-GLYCOPROTEIN III, ANTIGEN, ANTISERUM, CONTROLI866.5440
IMDADHAPTOGLOBIN, ANTIGEN, ANTISERUM, CONTROLII866.5460
IMDDGTRANSFERRIN, ANTIGEN, ANTISERUM, CONTROLII866.5880
IMCZOINTER-ALPHA TRYPSIN INHIBITOR, ANTIGEN, ANTISERUM, CONTROLI866.5890
CHCIXBROMCRESOL GREEN DYE­BINDING, ALBUMINII862.1035
CHCJWBROMCRESOL PURPLE DYE­BINDING, ALBUMINII862.1035
CHCJZACID, HYDROXYAZOBENZENE­BENZOIC, ALBUMINII862.1035
CHCJFTETRABROMOPHENOLPHTHALEIN, ALBUMINII862.1035
CHCJQRADIAL IMMUNODIFFUSION, ALBUMINII862.1035
CHCJGTETRABROMO­M­CRESOLSULFONPHTHALEIN, ALBUMINII862.1035
CHCJCFRUCTOSE­1, 6­DIPHOSPHATE AND NADH (U.V.), ALDOLASEI862.1040
CHCJTHYDRAZONE COLORIMETRY, ALDOLASEI862.1040
CHJKLACID, DELTA­AMINOLEVULINIC, ION­EXCHANGE COLUMNS WITH COLORIMETRYI862.1060
CHJIDPHOTOMETRIC METHOD, AMMONIAI862.1065
CHJIFENZYMATIC METHOD, AMMONIAI862.1065
CHJIGELECTRODE, ION­SPECIFIC METHOD, AMMONIAI862.1065
CHJIEMETHOD, ION­EXCHANGE, AMMONIAI862.1065
CHCIZRADIOIMMUNOASSAY, ANDROSTENEDIONEI862.1075
CHCIYRADIOIMMUNOASSAY, ANDROSTERONEI862.1080
CHJMAACID, ASCORBIC, 2,4­DINITROPHENYLHYDRAZINE (SPECTROPHOTOMETRIC)I862.1095
CHCISHYDRAZONE COLORIMETRY, AST/SGOTII862.1100
CHCITNADH OXIDATION/NAD REDUCTION, AST/SGOTII862.1100
CHCIQDIAZO, AST/SGOTII862.1100
CHCIFVANILLIN PYRUVATE, AST/SGOTII862.1100
CHJJBAZO­DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON­QUANT.)I862.1115
CHJKWN­ACETYL­L­TYROSINE ETHYL ESTER (U.V.), CHYMOTRYPSINI862.1180
CHJKXN­BENZOYL­L­TYROSINE ETHYL ESTER (U.V.), CHYMOTRYPSINI862.1180
CHCHERADIOIMMUNOASSAY, CORTICOIDSI862.1195
CHJKCRADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE)I862.1245
CHCGNACID, FOLIC, RADIOIMMUNOASSAYII862.1295
CHJGETURBIDIMETRIC METHOD, GLOBULINI862.1330
CHJGDNEPHELOMETRIC METHOD, GLOBULINI862.1330
CHJGCTRYPTOPHAN MEASUREMENT (COLORIMETRIC), GLOBULINI862.1330
CHCGHELECTROPHORETIC, GLOBULINI862.1330
CHJPZCOLORIMETRIC METHOD, GAMMA­GLUTAMYL TRANSPEPTIDASEI862.1360
CHJQAELECTROPHORETIC, GAMMA­GLUTAMYL TRANSPEPTIDASE ISOENZYMESI862.1360
CHJQBKINETIC METHOD, GAMMA­GLUTAMYL TRANSPEPTIDASEI862.1360
CHCCZZIMMERMAN/NORYMBERSKI, 17­KETOGENIC STEROIDSI862.1385
CHJHERADIOASSAY, 17­HYDROXYCORTICOSTEROIDSI862.1385
CHCDBPORTER SILBER HYDRAZONE, 17­HYDROXYCORTICOSTEROIDSI862.1385
CHJHDFLUOROMETRIC METHOD, 17­HYDROXYCORTICOSTEROIDSI862.1385
CHJIZATOMIC ABSORPTION, IRON (NON­HEME)I862.1410
CHJJARADIO­LABELED IRON METHOD, IRON (NON­HEME)I862.1410
CHJIYPHOTOMETRIC METHOD, IRON (NON­HEME)I862.1410
CHCFMBATHOPHENANTHROLINE, COLORIMETRY, IRON (NON­HEME)I862.1410
CHJQFBATHOPHENANTHROLINE, IRON BINDING CAPACITYI862.1415
CHJMOFERROZINE (COLORIMETRIC) IRON BINDING CAPACITYI862.1415
CHJQDRESIN, ION­EXCHANGE, THIOGLYCOLIC ACID, COLORIMETRY, IRON BINDING CAPACITYI862.1415
CHJQERESIN, ION­EXCHANGE, ASCORBIC ACID, COLORIMETRY, IRON BINDING CAPACITYI862.1415
CHJQGRADIOMETRIC, FE59, IRON BINDING CAPACITYI862.1415
CHCCYZIMMERMAN (SPECTROPHOTOMETRIC), 17­KETOSTEROIDSI862.1430
CHCFHTETRAZOLIUM INT DYE­DIAPHORASE, LACTATE DEHYDROGENASEII862.1440
CHCER2,4­DINITROPHENYLHYDRAZINE, LACTATE DEHYDROGENASEII862.1440
CHCFJNAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASEII862.1440
CHJGGL­LEUCINE­4­NITROANILIDE (COLORIMETRIC), LEUCINE ARYLAMIDASEI862.1460
CHCDCL­LEUCYL B­NAPHTHYLAMIDE, LEUCINE AMINOPEPTIDASEI862.1460
CHJMSACID, OXALACETIC AND NADH OXIDATION (U.V.), MALIC DEHYDROGENASEI862.1500
CHJQNCOLORIMETRIC, MUCOPOLYSACCHARIDESI862.1505
CHLPWSYSTEM, TEST, OXALATEI862.1542
CHCEOPHOSPHOMOLYBDATE (COLORIMETRIC), INORGANIC PHOSPHORUSI862.1580
CHJGRREFRACTOMETRIC, TOTAL PROTEINII862.1635
CHJGQTURBIDIMETRIC, TOTAL PROTEINII862.1635
CHJGPLOWRY (COLORIMETRIC), TOTAL PROTEINII862.1635
CHCEKBIURET (COLORIMETRIC), TOTAL PROTEINII862.1635
CHJIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON­QUANT.)I862.1645
CHJIQTURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON­QUANT.)I862.1645
CHJJSCONTROLS FOR BLOOD­GASES, (ASSAYED AND UNASSAYED)I862.1660
CHJJWURINALYSIS CONTROLS (ASSAYED AND UNASSAYED)I862.1660
CHJJTENZYME CONTROLS (ASSAYED AND UNASSAYED)I862.1660
CHJJXSINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)I862.1660
CHJJRELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED)I862.1660
CHJJYMULTI­ANALYTE CONTROLS, ALL KINDS (ASSAYED AND UNASSAYED)I862.1660
CHJNON­BENZOYL­L­ARGININE ETHYL ESTER (U.V.), TRYPSINI862.1725
CHJNNP­TOLUENESULPHONYL­L­ARGININE METHYL ESTER (U.V.), TRYPSINI862.1725
CHJNPINFRARED SPECTROSCOPY MEASUREMENT, URINARY CALCULI (STONE)I862.1780
CHJNQQUALITATIVE CHEMICAL REACTIONS, URINARY CALCULI (STONE)I862.1780
TXDKOADSORBENTS, ION­EXCHANGEI862.2230
TXDMGPAPERS, IONI862.2230
TXKEARESINS, ION­EXCHANGEI862.2230
TXDMSGASES, GLCI862.2250
TXDJACOLUMN SUPPORTS, GLCI862.2250
TXDLGCOATING, LIQUID, GLCI862.2250
TXLEQDETECTORS, ELECTROCHEMICAL, LIQUID CHROMATOGRAPHYI862.2260
TXDMZLIQUID CHROMATOGRAPHY, ADSORBENTI862.2260
TXDNHRESINS, ION­EXCHANGE, LIQUID CHROMATOGRAPHYI862.2260
TXDPAAPPARATUS, GENERAL USE, THIN LAYER CHROMATOGRAPHYI862.2270
TXDLYPLATE, ALUMINA, TLCI862.2270
TXDLCATOMIZER, TLCI862.2270
TXDLOINDICATOR, SILICA GEL FLUORESCENT, TLCI862.2270
TXDJOINDICATOR, CELLULOSE FLUORESCENT, TLCI862.2270
TXDJSU.V. LIGHT, TLCI862.2270
TXDKGPLATE, CELLULOSE, TLCI862.2270
TXDKKTANKS, DEVELOPING, TLCI862.2270
TXDKSPLATE, SILICA GEL, TLCI862.2270
TXDKYINDICATOR, ALUMINA FLUORESCENT, TLCI862.2270
TXDIFDRUG MIXTURE CONTROL MATERIALSI862.3280
TXDIEHEAVY METALS CONTROL MATERIALSI862.3280
TXLAXLIDOCAINE CONTROL MATERIALSI862.3280
TXLAWTHEOPHYLLINE CONTROL MATERIALSI862.3280
TXLAZN­ACETYLPROCAINAMIDE CONTROL MATERIALSI862.3280
TXLAYMETHOTREXATE CONTROL MATERIALSI862.3280
TXLASDRUG SPECIFIC CONTROL MATERIALSI862.3280
TXDMPDIGOXIN CONTROL SERUM, RIAI862.3280
TXDKCALCOHOL CONTROL MATERIALSI862.3280
TXDJKDIGITOXIN CONTROL SERUM, RIAI862.3280
TXLBAPROCAINAMIDE CONTROL MATERIALSI862.3280
HEGHKCENTRIFUGE, MICROSEDIMENTATIONI864.5350
HEGIOTUBE, COLLECTION, CAPILLARY BLOODI864.6150
HEJIOBLOOD, OCCULT, COLORIMETRIC, IN URINEII864.6550
HEJIPBLOOD, OCCULT, ENZYMATIC METHOD, IN URINEII864.6550
MIJTYCULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIAII866.2410
MIJSPKIT, ANAEROBIC IDENTIFICATIONI866.2660
MIJSRKIT, IDENTIFICATION, DERMATOPHYTEI866.2660
MIJSSKIT, IDENTIFICATION, ENTEROBACTERIACEAEI866.2660
MIJSWKIT, IDENTIFICATION, GLUCOSE NONFERMENTERI866.2660
MIJSZKIT, IDENTIFICATION, PSEUDOMONASI866.2660
MIJTODISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATIONI866.2660
MILIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTICI866.2660
MILJGQUALITY CONTROL SLIDESI866.2660
MILQLGRAM POSITIVE IDENTIFICATION PANELI866.2660
MILQMGRAM NEGATIVE IDENTIFICATION PANELI866.2660
MILKSDEVICE, PARASITE CONCENTRATIONI866.2900
MIJWTANTIGEN, CF, ASPERGILLUS SPP.I866.3040
MIGSNANTISERUM, POSITIVE AND NEGATIVE FEBRILE ANTIGEN CONTROL SERUMII866.3085
MIGSOANTIGENS (FEBRILE), AGGLUTINATION, BRUCELLA SPP.II866.3085
MIGMGANTIGEN, LATEX AGGLUTINATION, COCCIDIOIDES IMMITISII866.3135
MIGMIANTIGEN, CF AND/OR ID, COCCIDIOIDES IMMITISII866.3135
MIGOPANTISERA, C. ACNES (553, 605)I866.3140
MIKLHANTISERA, C. ACNESI866.3140
MIGNGANTIGENS, CF (INCLUDING CF CONTROL), COXSACKIEVIRUS A 1­24, B 1­6I866.3145
 
MIGNNANTISERA, NEUTRALIZATION, COXSACKIEVIRUS A 1­24, B 1­6I866.3145
MIGNOANTISERA, CF, COXSACKIEVIRUS A 1­24, B 1­6I866.3145
MIGQHANTIGEN, CF (INCLUDING CF CONTROL), CYTOMEGALOVIRUSII866.3175
MIGQIANTISERUM, CF, CYTOMEGALOVIRUSII866.3175
MILJOANTIGEN, IHA, CYTOMEGALOVIRUSII866.3175
MIGNQANTIGEN, CF (INCLUDING CF CONTROL), EPSTEIN­BARR VIRUSI866.3235
MIGQCANTISERA, CF, EQUINE ENCEPHALITIS VIRUS, EEE, WEEI866.3240
MIGQDANTIGENS, CF (INCLUDING CF CONTROL), EQUINE ENCEPHALITIS VIRUS, EEE, WEEI866.3240
MIGQNANTIGEN, CF (INCLUDING CF CONTROL), HERPESVIRUS HOMINIS 1,2III866.3305
MIGQOANTISERA, CF, HERPESVIRUS HOMINIS 1,2III866.3305
MILKCANTIGENS, INDIRECT HEMAGGLUTINATION (IHA) HERPES SIMPLEX VIRUSIII866.3305
MIGQJANTISERUM, CF, LYMPHOCYTIC CHORIOMENINGITIS VIRUSI866.3360
MIGQKANTIGEN, CF, LYMPHOCYTIC CHORIOMENINGITIS VIRUSI866.3360
MIGSBANTIGENS, CF, ALL, MYCOPLASMA SPP.I866.3375
MIGQYANTIGEN, HA (INCLUDING HA CONTROL), MUMPS VIRUSI866.3380
MIGQZANTISERUM, NEUTRALIZATION, MUMPS VIRUSI866.3380
MIGRBANTISERUM, CF, MUMPS VIRUSI866.3380
MIGRCANTIGEN, CF (INCLUDING CF CONTROL), MUMPS VIRUSI866.3380
MIGRDANTISERUM, HAI, MUMPS VIRUSI866.3380
MIGOGANTISERA, CF, POLIOVIRUS 1­3I866.3405
MIGOHANTIGENS, CF (INCLUDING CF CONTROL), POLIOVIRUS 1­3I866.3405
MIGQGANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUSI866.3480
MIGPOANTIGEN, CF, TYPHUS FEVER GROUPI866.3500
MIGPQANTIGEN, CF, SPOTTED FEVER GROUPI866.3500
MIGPRANTISERUM, CF, Q FEVERI866.3500
MIGPSANTIGEN, CF, Q FEVERI866.3500
MIGOKANTISERA, HAI (INCLUDING HAI CONTROL), RUBELLAIII866.3510
MIGOLANTIGEN, HA (INCLUDING HA CONTROL), RUBELLAIII866.3510
MIGOMANTISERA, CF, RUBELLAIII866.3510
MIGONANTIGEN, CF (INCLUDING CF CONTROL), RUBELLAIII866.3510
MIGNCANTIGENS, FEBRILE, SLIDE AND TUBE, ALL GROUPS, SLAMONELLA SPP.II866.3550
MIGOOANTISERA, FLUORESCENT, ALL GLOBULINS, SALMONELLA SPP.II866.3550
MIGRLANTIGENS, ALL GROUPS, SALMONELLA SPP.II866.3550
MIGRMANTISERA, ALL GROUPS, SALMONELLA SPP.II866.3550
MIGLZANTIGENS, IF, TOXOPLASMA GONDIIII866.3780
MIGMMANTIGENS, IHA, TOXOPLASMA GONDIIII866.3780
MIGMNANTIGENS, CF, TOXOPLASMA GONDIIII866.3780
MIGNDANTIGEN, IHA, T. CRUZII866.3870
MIGNFANTIGEN, CF, T. CRUZII866.3870
MIGQWANTIGEN, CF, (INCLUDING CF CONTROL), VARICELLA­ZOSTERII866.3900
MIGQXANTISERUM, CF, VARICELLA­ZOSTERII866.3900

 

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