In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions - Appendix A - 510(k) Submission/Clinical Chemistry

 IVD Manual Appendixes Index

APPENDIX A - 510(k) SUBMISSION/CLINICAL CHEMISTRY
This is an example of a "model" 510(k) submission for a Blood Gas/Blood pH Analyzer that is intended for use in a point-of-care or bedside environment. The 510(k) included the following elements:

Content and Format of a 510(k) Submission as specified under 21 CFR 807.90:

1. Submitter's Name
   Address
   Telephone and Fax Number
   Contact Person
   Establishment Registration Number: XXXXXX
   
2. Identification of the Device:

   	Device Name:	XXXXXX
   	Proprietary/Trade name:	XXXXXX
   	Common Name:	Blood gas analyzer
   	Classification Name:	Blood gases and (PCO2, PO2) and blood pH test system
   	Device Classification:	II
   	Regulation Number:	21 CFR § 862.1120
   	Panel:	Chemistry (75)
   	Product Code:	CHL

3. Identification of the Predicate Device:
   Predicate Device Name
   Manufacturer
   510(k) Number or Clearance Information
   Predicate Device Labeling
4. Description of the Device and reason for the submission
5. Intended Use and Indications for Use of the subject device.

6. Substantial Equivalence

   A discussion of how the device is substantially equivalent to the claimed predicate device. Relevant topics include a descriptive comparison of the following items: methodology, test principle, sample requirements, physical dimensions, throughput, analysis time, software support, calibration requirements, etc.
   

   Technological Characteristics of the Device

   A discussion of information concerning the operation, function, methodology, and principles of the subject device.

   Performance Characteristics and Data

   A discussion of the performance data that was generated in support of the device including protocols, raw data points, graphical representation, and analyses or conclusions for the following parameters as applicable:

   Specific Performance Characteristics and Data
   Method Comparison - a method comparison for each sample or matrix claimed for analysis, e.g., whole blood, capillary whole blood, serum, plasma, urine, etc.	¨ slope ¨ intercept ¨ range of samples ¨ correlation ¨ standard error est. ¨ bias plot ¨ number (n=) ¨ sample comparability
   Precision - precision information using quality control materials or patient pools for each matrix claimed for analysis.	¨ within-run (assay), and ¨ between-run (assay), or ¨ total ¨ calculated CV's & SD's ¨ mean ¨ number (n=)
   Linearity	¨ recovery/dilution/parallelism, other, etc. ¨ linear range study
   Sensitivity	¨ min. detection limit, or ¨ analytical sensitivity
   Interferences	¨ bilirubin ¨ hemoglobin ¨ lipids (triglycerides) ¨ other, drugs, anticoagulants, etc.
   Clinical Studies for Near Patient or Bedside Use	¨ location of studies (3 sites) ¨ investigators ¨ site precision ¨ site comparison
   Software	¨ validation/certification information
   Expected Values	¨ literature references, or ¨ population study

   Labeling/Promotional Materials

   Provide a copy of the labeling in draft. Labeling should be conformance to the format and order of 21 CFR 809.10(b) (see below). An explanation should be provided for each element that is either absent or not applicable.

   21 CFR § 809.10 Labeling for In Vitro DiagnosticDevices

   21 CFR § 809.10(b) - labeling accompanying each product (package insert) shall bear...in the format and order specified below except where not applicable:
   (1)	Proprietary & Established Names
   (2)	Intended Use(s) Conditions for Use* 21 CFR § 801.5 (a)	- state the analyte to be measured - state if the test is quantitative or qualitative - state the specimen type(s) - state any special instrument requirements - state a concise claim of clinical utility - "For Professional Use Only" - state any special condition for use statement(s)
   (3)	Summary & Explanation
   (4)	Test Principle
   (5)	Reagents	- quantity, proportion, or concentration - biological material (source/measure of activity) - precautions, warnings - "For In Vitro Diagnostic Use" - instructions for reconstitution, mixing, or dilution - storage instructions (opened/unopened)
   (6)	For Instruments:	Operation Manual - name - use/function - installation requirements - principles of operation - performance characteristics/specifications - operating instructions - calibration procedures - precautions/limitations - hazards - service/maintenance requirements
   (7)	Specimen Collection & Preparation	- any special precautions or patient preparation - any specimen additives, preservatives - any known interferences - storage, handling requirements
   (8)	Procedure	- a list of materials provided - a list of materials required but not provided - step by step instructions - a description of the stability of the final reaction - details of calibration - details of quality control
   (9)	Results	- sample calculation or formula - description of the results
   (10)	Limitations	- interferences - additional testing requirements
   (11)	Expected Values	- stated range(s) - literature references - population characterization
   (12)	Specific Performance Characteristics	- accuracy (method comparison) - precision - specificity (cross-reactivity, etc.) - sensitivity (lower detection limit) - dilution/recovery/linearity - sample comparability - high dose hook effect
   (13)	Bibliography
   (14)	Name/place of manufacturer, packer, or distributor
   (15)	Date of last labeling revision

   Other: For a multi-purpose instrument used for diagnostic purposes...may bear the information in (b) (1), (2), (6), (14), and (15).
   
   
7. Summary of Safety and Effectiveness in the format specified under 21 CFR 807.92 or 510(k) Statement in the content and format specified under 21 CFR 807.93
8. Truthful and Accurate Statement
9. Indications for Use Form