Coatest SP FVIII is intended for the photometric determination of factor VIII activity in citrated plasma, such as when identifying factor VIII deficiency or monitoring patients on replacement therapy, as well as for potency estimation of FVIII concentrates. For in vitro diagnostic use.

Device Description

AI/ML Overview

This device is a Factor Deficiency Test, specifically for Factor VIII. The provided text describes a 510(k) summary for the Coatest SP FVIII, demonstrating its substantial equivalence to a predicate device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the statement: "the slopes and correlation coefficients (r) obtained for Coatest SP FVIII versus the following reference methods showed statistically similar performances." While no explicit numerical thresholds for acceptance are given (e.g., "slope must be between X and Y"), the reported values are presented as evidence of meeting this general criterion of "statistically similar performances."

Acceptance Criteria (Implied)	Performance Measure	Reference Method	n	Reported Performance (Slope)	Reported Performance (r)
Statistically similar performance to predicate device	Method Comparison (Slope)	Coatest FVIII (K833892)	181	1.0851	0.9873
Statistically similar performance to predicate device	Method Comparison (Slope)	Coamatic FVIII (K981038)	90	0.9987	0.9919
Satisfactory within-run and total precision	Within-run CV%	High Abnormal Control	80*	4.3%	-
Satisfactory within-run and total precision	Within-run CV%	Normal Control	80*	3.4%	-
Satisfactory within-run and total precision	Total CV%	High Abnormal Control	80*	5.6%	-
Satisfactory within-run and total precision	Total CV%	Normal Control	80*	5.3%	-
Satisfactory within-run and total precision	Within-run CV%	High Abnormal Control	80*	5.7%	-
Satisfactory within-run and total precision	Within-run CV%	Normal Control	80*	4.7%	-
Satisfactory within-run and total precision	Total CV%	High Abnormal Control	80*	6.3%	-
Satisfactory within-run and total precision	Total CV%	Normal Control	80*	7.1%	-

*Note: The 'n' for precision is "multiple runs (n=80)", implying 80 runs were conducted for the precision assessment, though the specific number of unique samples contributing to each CV% is not detailed.

2. Sample Size Used for the Test Set and Data Provenance

Method Comparison Test Set (Manual Method vs. Coatest FVIII (K833892)): n = 181
Method Comparison Test Set (ACL 9000 vs. Coamatic FVIII (K981038)): n = 90
Precision Test Set: "multiple runs (n=80)" for both normal and abnormal samples.
Data Provenance: Not explicitly stated (e.g., country of origin). It is retrospective in the sense that existing samples are being tested and compared to established methods, but the text doesn't specify if these were newly collected prospective samples or archived retrospective samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a diagnostic assay for quantitative measurement of Factor VIII activity. Ground truth is established by the results of the reference methods (predicate device and another similar device), not by expert human interpretation of images or other subjective data.

4. Adjudication Method for the Test Set

Not applicable. Ground truth is based on reference assay results, not on expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where multiple human readers assess cases. This device is a quantitative assay.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is essentially a standalone (algorithm only) performance study. The device, Coatest SP FVIII, is a reagent kit and associated photometric measurement system that performs automated/semi-automated quantitative measurements. Its performance is evaluated independently against established reference methods. Human involvement is in running the test and interpreting the numerical output, but the analytical performance described (slopes, correlation, precision) is intrinsic to the device system itself.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established by reference methods (predicate device: Coatest Factor VIII (K833892) and another established method: Coamatic FVIII (K981038)) which are considered clinical standards for Factor VIII activity determination.

8. The Sample Size for the Training Set

Not applicable. This is a traditional in-vitro diagnostic (IVD) device, not an AI/Machine Learning algorithm that typically requires a distinct "training set." The system is based on an enzymatic reaction and photometric measurement, not on a learned model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no specific "training set" in the context of an AI/ML algorithm for this type of IVD device. The reagents and assay parameters are developed and optimized through standard biochemical and analytical chemistry principles.

Summary

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K042576

DEC - 2 2004

Section 3 Coatest SP FVIII - 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

September 21, 2004

Name of the Device:

Coatest SP FVIII

Classification Name:

864.7290 Factor Deficiency Test Class II 81GGP Test, Qualitative and Quantitative Factor Deficiency

Identification of predicate device:

K833892 Coatest Factor VIII

Description of the device:

Statement of Technological Characteristics of the Device Compared to Predicate Device:

Coatest SP FVIII is substantially equivalent in performance and safety and effectiveness to the predicate device: Coatest Factor VIII.

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Section 3 (Cont.) Coatest SP FVIII - 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In method comparison studies evaluating citrated plasma samples, the slopes and correlation coefficients (r) obtained for Coatest SP FVIII versus the following reference methods showed statistically similar performances:

	Reference Method	n	Slope	r
Manual Method	Coatest FVIII (K833892)	181	1.0851	0.9873
ACL 9000	Coamatic FVIII (K981038)	90	0.9987	0.9919

Precision

Within run and total precision was assessed over multiple runs (n=80) using both normal and abnormal samples:

	Control	Mean% Factor VIII	Within runCV%	TotalCV%
ManualMethod	High Abnormal Control	14.4	4.3	5.6
	Normal Control	83	3.4	5.3
ACL 9000	High Abnormal Control	17.3	5.7	6.3
	Normal Control	102	4.7	7.1

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421

DEC - 2 2004

Re: K042576

Trade/Device Name: Coatest SP FVIII Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: November 9, 2004 Received: November 10, 2004

Dear Ms. Marble:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, rryou don't specific most on advertising of your device, please contact the Office of In or questions on the process Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the r ou may outmer generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coatest SP FVIII

Indications for Use:

For in vitro diagnostic use.

V Prescription Use _ (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KC42576

Coatest SP FVIII 510(k)

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).