ChromoCheck™ Protein C is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.

Device Description

ChromoCheck™ Protein is a chromogenic assay consisting of a synthetic substrate and Protein C Activator.

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Correlation Study)
Substantial Equivalence	R² values of 0.990 and 0.994
- Predictive Power (R²)	Y-intercepts: 0.632, -1.308
- Accuracy (Y-intercept)	Slopes: 0.979, 1.025
- Agreement (Slope)

Note: The document does not explicitly state numerical acceptance criteria in the traditional sense (e.g., "R² must be > 0.95"). Instead, the performance demonstrated in the correlation study with the predicate device is presented as evidence for substantial equivalence, implying that these results met the FDA's criteria for such a determination. The strong correlation (high R² values and slopes close to 1 with small Y-intercepts) is the key indicator of acceptance.

Study Details

2. Sample Size and Data Provenance

Sample Size for Test Set: 60 individual normal and pathological patient samples.
Data Provenance: Not explicitly stated, but the submission is from a Canadian company (Precision BioLogic Incorporated, Dartmouth, Nova Scotia, Canada). The predicate device manufacturer is Swedish (Chromogenix AB, Molndal, Sweden). It's not specified where the 60 patient samples were collected, but given the context of a correlation study for a device intended for clinical use, they would be human plasma samples. The text doesn't specify if it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The "ground truth" here is the measurement obtained from the predicate device (Coamatic Protein C).

4. Adjudication Method

None explicitly stated. The study compares the new device's results directly to the predicate device's results. There's no mention of multiple interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. This device is an in vitro diagnostic (IVD) assay, not an imaging or diagnostic aid that typically involves human readers. The comparison is between two laboratory assays.

6. Standalone Performance Study

Yes, in essence. The correlation study evaluates the performance of the ChromoCheck™ Protein C device directly against a legally marketed predicate device (Coamatic Protein C). While it's a comparative study, the reported metrics (Y-intercept, Slope, R²) describe the standalone performance relative to a reference standard (the predicate). There's no human-in-the-loop for this type of IVD.

7. Type of Ground Truth Used

Comparison to a Legally Marketed Predicate Device: The ground truth for this study was established by comparing the results of the ChromoCheck™ Protein C assay to the results obtained from the Coamatic Protein C, which is a legally marketed device previously cleared by the FDA (K922201). This is a common approach for establishing substantial equivalence for IVDs. The "truth" is assumed to be accurately measured by the predicate device.

8. Sample Size for Training Set

The document does not mention a separate training set or its sample size. For an IVD assay like this, development and optimization would occur, but the provided text focuses on the performance validation (correlation study).

9. How Ground Truth for Training Set Was Established

As no training set is explicitly mentioned, this information is not provided.

Summary

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510(K) Summary ChromoCheck™ Protein C

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _K023990

Submitters Name &Address:	Precision BioLogic Incorporated900 Windmill Road, Suite 100Dartmouth, Nova Scotia B3B 1P7Canada
Contact Name:	Stephen L. Duff - Director of New BusinessDevelopmentPhone: 902-468-6422 ext. 224Fax: 902-468-6421Email: sduff@precisionbiologic.com
Preparation Date:	November 18, 2002
Device Name &Classification:	ChromoCheck™ Protein CCommon Name: Protein C chromogenic assayClassification Name: Test, Quantitative factordeficiencyRegulatory Class II, 81 GGP
Predicate Device:	Chromogenix AB/Instrumentation LaboratoryTaljegardsgatan 3S-431 53 MolndalSweden, SW
Device Description:	ChromoCheck™ Protein is a chromogenic assayconsisting of a synthetic substrate and Protein CActivator.
Device Intended Use:	ChromoCheck™ Protein C is intended for use as achromogenic assay for the quantitativedetermination of Protein C activity in citrated humanplasma.

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Comparison to Predicate Device:

Parameter	ChromoCheck™ Protein C	Coamatic Protein C
IntendedUse	Test, Quantitative factordeficiency	Test, Quantitative factordeficiency
Analytes	Protein C activity	Protein C activity
ComponentReagentMatrices	Reagent 1: Chromogenicsubstrate in distilled water matrixReagent 2: Protein C activator ina distilled water matrix	Reagent 1: Chromogenicsubstrate in distilled water matrixReagent 2: Protein C activator in adistilled water matrix
Format	Lyophilized	Lyophilized
Packaging	4 x Protein C Activator (0.65 IU)4 x Substrate (4 mg)(Reconstituted volume - 2.5 mL)4 x Protein C Activator (0.65 IU)4 x Substrate (4 mg)(Reconstituted volume - 5.0 mL)	2 x Protein C Activator (1.2 IU)2 x Substrate S-2366 (6 mg)(Reconstituted volume - 7.2 mL)

Comments on Substantial Equivalence:

It is the opinion of Precision BioLogic Inc. that ChromoCheck™ PC is substantially equivalent to Coamatic Protein C (K922201), manufactured by Chromogenix AB, and currently marketed in the United States by Instrumentation Laboratory. This opinion is based on the following similarities:

1. Both products are intended for use in the quantitative determination of Protein C activity in citrated human plasma
1. Both devices are based on synthetic chromogenic substrates
1. Both devices contain a synthetic chromogenic substrate and Protein C Activator and are reconstituted with distilled water
1. Both devices present results as a % activity of Protein C
1. Both devices are offered in a lyophilized format

Correlation:

Two lot numbers of ChromoCheck™ Protein C were compared to Coamatic Protein C in a correlation study using a mix of 60 individual normal and pathological patient samples. The following correlation was achieved:

Correlationparameter	ChromoCheckLot 1	ChromoCheckLot 2
Y-intercept	0.632	-1.308
Slope	0.979	1.025
R2	0.990	0.994

Conclusion: ChromoCheck™ Protein C is substantially equivalent to Coamatic Protein C.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, serif font. The text is all in uppercase letters. The text is centered in the image.

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Mr. Stephen L. Duff Director of New Business Development Precision BioLogic Inc. 900 Windmill Road, Suite 100 Dartmouth. Nova Scotia Canada B3B 1P7

MAR 1 9 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: K023990

Trade/Device Name: ChromoCheck™ Protein C Regulation Number: 21 CFR & 864.7290 Regulation Name: Quantitative Factor Deficiency Test Regulatory Class: II Product Code: GGP Dated: February 26, 2003 Received: February 27, 2003

Dear Mr. Duff:

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, 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). You may obtain other general information on your responsibilities under the Act 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:	KO23990
Device Name:	ChromoCheck™ Protein C

Indications for Use:

ChromoCheck™ Protein C is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma.

Josephine Bautista

(Sign-Off)
of Clinical Laboratory Devices K023990
Number

/ Prescription Use

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).