CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50

K023990 · Precision Biologic · GGP · Mar 19, 2003 · Hematology

Device Facts

• Record ID: K023990
• Device Name: CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50
• Applicant: Precision Biologic
• Product Code: GGP · Hematology
• Decision Date: Mar 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended 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.

Device Story

ChromoCheck™ Protein C is an in vitro diagnostic chromogenic assay used to quantify Protein C activity in citrated human plasma. The device consists of a synthetic chromogenic substrate and a Protein C activator. Upon addition to a patient plasma sample, the activator converts Protein C to activated Protein C, which then acts on the synthetic substrate to produce a measurable color change. The assay is performed in a clinical laboratory setting by trained personnel. Results are expressed as a percentage of Protein C activity. Healthcare providers use these quantitative results to assess Protein C deficiency, aiding in the diagnosis and management of coagulation disorders.

Clinical Evidence

Bench testing only. A correlation study compared two lots of ChromoCheck™ Protein C against the predicate device (Coamatic Protein C) using 60 individual normal and pathological patient samples. Results showed high correlation with R2 values of 0.990 and 0.994, slopes of 0.979 and 1.025, and y-intercepts of 0.632 and -1.308, respectively.

Technological Characteristics

In vitro diagnostic chromogenic assay. Components: synthetic chromogenic substrate and Protein C activator, both in distilled water matrix. Format: lyophilized. Principle: enzymatic activation of Protein C followed by chromogenic substrate cleavage. Quantitative measurement of Protein C activity.

Indications for Use

Indicated for the quantitative determination of Protein C activity in citrated human plasma for patients requiring assessment of Protein C deficiency.

Predicate Devices

• Coamatic Protein C (K922201)

Submission Summary (Full Text)

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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 &<br>Address: | Precision BioLogic Incorporated<br>900 Windmill Road, Suite 100<br>Dartmouth, Nova Scotia B3B 1P7<br>Canada |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name: | Stephen L. Duff - Director of New Business<br>Development<br>Phone: [phone] ext. 224<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | November 18, 2002 |
| Device Name &<br>Classification: | ChromoCheck™ Protein C<br>Common Name: Protein C chromogenic assay<br>Classification Name: Test, Quantitative factor<br>deficiency<br>Regulatory Class II, 81 GGP |
| Predicate Device: | Chromogenix AB/Instrumentation Laboratory<br>Taljegardsgatan 3<br>S-431 53 Molndal<br>Sweden, SW |
| Device Description: | ChromoCheck™ Protein is a chromogenic assay<br>consisting of a synthetic substrate and Protein C<br>Activator. |
| Device Intended Use: | ChromoCheck™ Protein C is intended for use as a<br>chromogenic assay for the quantitative<br>determination of Protein C activity in citrated human<br>plasma. |

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### Comparison to Predicate Device:

| Parameter | ChromoCheck™ Protein C | Coamatic Protein C |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Test, Quantitative factor<br>deficiency | Test, Quantitative factor<br>deficiency |
| Analytes | Protein C activity | Protein C activity |
| Component<br>Reagent<br>Matrices | Reagent 1: Chromogenic<br>substrate in distilled water matrix<br>Reagent 2: Protein C activator in<br>a distilled water matrix | Reagent 1: Chromogenic<br>substrate in distilled water matrix<br>Reagent 2: Protein C activator in a<br>distilled water matrix |
| Format | Lyophilized | Lyophilized |
| Packaging | 4 x Protein C Activator (0.65 IU)<br>4 x Substrate (4 mg)<br>(Reconstituted volume - 2.5 mL)<br><br>4 x Protein C Activator (0.65 IU)<br>4 x Substrate (4 mg)<br>(Reconstituted volume - 5.0 mL) | 2 x Protein C Activator (1.2 IU)<br>2 x Substrate S-2366 (6 mg)<br>(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
- 2. Both devices are based on synthetic chromogenic substrates
- 3. Both devices contain a synthetic chromogenic substrate and Protein C Activator and are reconstituted with distilled water
- 4. Both devices present results as a % activity of Protein C
- 5. 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:

| Correlation<br>parameter | ChromoCheck<br>Lot 1 | ChromoCheck<br>Lot 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.

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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 [phone]. 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 [phone] or [phone] 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

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