Coatest Factor VIII was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIII activity in citrated plasma. For in vitro diagnostic use.

Device Description

Coatest Factor VIII (K833892) was modified to substitute the natural porcine phospholipids in the Phospholipid reagent with synthetic phospholipids. This modification does not alter the fundamental scientific technology of the device or its intended use for the photometric determination of Factor VIII activity in citrated plasma.

AI/ML Overview

The Coatest Factor VIII (Modified) device is intended for the photometric determination of Factor VIII activity in citrated plasma. The modification involved substituting natural porcine phospholipids with synthetic phospholipids in the Phospholipid reagent. The study aimed to demonstrate substantial equivalence to the predicate device (Coatest Factor VIII, K833892).

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Coatest Factor VIII (Modified))
Precision	CV% should be within acceptable clinical limits (not explicitly stated but inferred from typical assay performance for factor VIII).
Within-run CV (Low range)		1.5%
Between-run CV (Low range)		2.3%
Within-run CV (High range)		1.4%
Between-run CV (High range)		2.4%
Method Comparison	High correlation and agreement with the predicate device (Coatest Factor VIII). Implicitly, the slope should be close to 1 and the intercept close to 0.	Slope = 1.002, Intercept = 0.365

Note: The acceptance criteria are not explicitly defined in the provided text. They are inferred based on the performance data presented and the claim of substantial equivalence to a predicate device. For precision, typical clinical laboratory standards would dictate acceptable CVs.

2. Sample size used for the test set and the data provenance:

Precision Test Set:
- Low Range: 90 samples
- High Range: 89 samples
- Provenance: Not specified, but likely from a controlled laboratory setting (e.g., control plasma samples). It is not specified if it's retrospective or prospective.
Method Comparison Test Set: The sample size for the method comparison study is not explicitly stated in numerical form. However, the table for method comparison has a column labeled "N" with "1. 20 Special..." which might indicate 20 samples were used. The sample range is given as "Californial . 47 % EVET 1...". This phrasing seems incomplete or garbled, and does not clearly specify the sample provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the given text. The study focuses on evaluating the analytical performance of the modified device (precision and method comparison), not on diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable or not provided. This type of adjudication is typically relevant for studies involving human interpretation (e.g., image analysis, clinical diagnosis), where disagreements among experts need to be resolved to establish ground truth. This study focuses on an in-vitro diagnostic device's analytical performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. This study is for an in-vitro diagnostic device (Factor VIII assay) and does not involve human readers interpreting cases or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance evaluation was done for the device. The precision and method comparison studies evaluate the device's analytical capabilities independent of human interpretation or intervention beyond standard laboratory procedures.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For precision studies, the "ground truth" is the expected concentration or true value of the control materials used, which are typically established through rigorous characterization and standardization by the manufacturer.

For method comparison, the reference method (predicate device Coatest Factor VIII) served as the comparator, with its measurements being the "gold standard" against which the modified device's measurements were compared.

8. The sample size for the training set:

Not applicable. This device is an in-vitro diagnostic assay, not a machine learning or AI algorithm that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable, as no training set was used.

Summary

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K033631

DEC 1 5 2003

Section 3 Coatest Factor VIII 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

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

Contact Person:

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

Summary Prepared:

November 18, 2003

Name of the Device:

Coatest Factor VIII (Modified)

Classification Name:

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

Identification of predicate device:

K833892 Coatest Factor VII

Description of the modified device:

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

The modified Coatest Factor VIII is substantially equivalent in performance, intended use, safety and effectiveness to the currently marketed Coatest Factor VIII.

Summary of Performance Data:

Within run and between run precision assessed over multiple runs in the low and high ranges using two levels of control plasma gave the results below:

Range	Control Level	n	Mean% FVIII	Within Run%CV	Between Run%CV
Low	Low	90	14.4	1.5	2.3
High	Normal	89	81.8	1.4	2.4

The following results were obtained in a method comparing the current legally marketed Coatest Factor VIII to the modified Coated Factor VIII:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	الموال	CALL CLASS COLLECT AIntercept		As all all of the store and the first the first the figure of the film to the collection of the film of the collection and the comments of the results of the second the seconSample Range
1. 20Special and the first and the company of the company of the company of the company of the company of the company of the company of the company of the company of the company o	1.002	0.365	0 085100 000	Californial. 47 % EVET1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 5 2003

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, MA 02421-3125

Re: K033631

Trade/Device Name: Coatest Factor VIII (Modified) Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: November 18, 2003 Received: November 19, 2003

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).

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Page 2 -

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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In, Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): K033631

Device Name: Coatest Factor VIII (Modified)

Indications for Use:

For in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device

Evaluation and Salety

510(k) K033631

Prescription Use
(Per 21 CFR 801.019)

Over-The-Counter Use

Section 2

Special 510(k): Coatest Factor VIII

Page 1 of 1

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).