Document issued on: July 6, 1998
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Chemistry Toxicology and Hematology Branch
Division of Clinical Laboratory Devices
Office of Device Evaluation
Comments and suggestions may be submitted at any time for Agency consideration to, Joseph L. Hackett, Ph.D., Division of Clinical Laboratory Devices, HFZ-440, 9200 Corporate Blvd, Rockville, MD 20850. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact Joseph L. Hackett, Ph.D., at 301 594-3084.
Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number (1102) to identify the guidance you are requesting.
Device: In Vitro Diagnostic Bicarbonate/Carbon Dioxide Test System
Common Name (s): Bicarbonate/Carbon Dioxide Test System
Classification Panel: Clinical Chemistry (75)
Product Codes CHS, Coulometric Method, Carbon-Dioxide CIL, Cresol Red Colorimetry, Carbon=Dioxide KHS, Enzymatic, Carbon-Dioxide JFL, pH Rate Measurement, Carbon-Dioxide KMS, Phenolphthalein Colorimetry, Carbon-Dioxide CHR, Titrimetric Phenol Red, Carbon-Dioxide CIE, Volumetric/Manometric, Carbon-Dioxide
Regulation numbers,: 21 CFR 862.1160
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood.
Indications for Use
Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The intended patient population may be adult, pediatric, and neonatal, while the environment of use may be a hospital (e.g., respiratory care or laboratory department), urgent care situations (e.g., intensive care unit, surgery, emergency department), or bedside/near patient care situations.
Specific Performance Characteristics
PreClinical/Laboratory/In Vitro Studies
The following eight performance characteristics (#1 Method Comparison - #8 Expected Values) should be included in the submission. Data should be provided that supports the use of the device with the specimen type(s) that are claimed to be appropriate for analysis:
- Method Comparison
-range of samples tested
-standard error of the estimate
-bias and bias plot
-number of samples tested
-plot of the data
-within-run (assay, and
-between-run (assay), or
-mean(s), standard deviation (s), and coefficient(s) of variation
-recovery, dilution, etc.
-minimum detection limit, or
-endogenous, e.g., bilirubin, hemoglobin, lipids, etc.
-exogenous, e.g., drugs, anticoagulants, etc.
- Stability Summary
-quality control interval
-quality control materials
- Expected Values
-literature reference (s), reference interval, or
-population study, reference interval,
-medical decision point(s) and/or
-critical decision point(s)
- Method Comparison
A method comparison study as described above, comparing performance with that of the predicate device as well as an appropriate reference method should be conducted to demonstrate substantial equivalence. A statistically significant sample of patients from a population representing the proposed intended use should be included in the study, spanning the appropriate assay range.
Total Measurement Error at selected decision points should be calculated and reported.
Refer to 21 CFR 809.10.
Other: For a multi-purpose instrument used for diagnostic purposes refer to 21 CFR 809.10 (b) (1),(2),(6),(14),and (15).
Instructions: Use this checklist for premarket notification for Bicarbonate/Carbon Dioxide System as a guide in preparing your submission.
Checklist Truthful and Accurate statement verbatim as per 21 CFR 807.87(j). 510(k) summary or statement per 21 CFR 807.92 or 21 CFR 807.93 respectively. Indications for use on a separate page. Labeling for in vitro diagnostic products (21 CFR 809.10 (b) Pre-Clinical Data: Interference Studies Linearity Studies Precision studies at medical decision levels Clinical Data (method comparison)
Methodologies to assist sponsors in establishing the specific performance characteristics addressed in part III of this document may be obtained using NCCLS documents or one of the following references:
Carey RN and Garber CC: Evaluation of Methods in Clinical Chemistry - theory, analysis, and correlation; Kaplan LA and Pesce AJ (eds), CV Mosby Company, St. Louis, 1984.
Koch DD and Peters T: Selection and Evaluation of Methods in Tietz Textbook of Clinical Chemistry (Burtis CA and Ashwood ER, WKB Saunders Co, Philadelphia, 1994.