CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5

K050448 · Horiba Abx · GGP · Sep 23, 2005 · Hematology

Device Facts

• Record ID: K050448
• Device Name: CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
• Applicant: Horiba Abx
• Product Code: GGP · Hematology
• Decision Date: Sep 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

Chromopep PC is intended for use as an in vitro chromogenic assay for the quantitative determination of Protein C activity in citrated human plasma. Chromopep AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

Device Story

Chromopep PC and Chromopep AT are in vitro diagnostic chromogenic assays used to quantify Protein C and antithrombin activity in citrated human plasma. Protein C assay utilizes Agkistrodon c. contortrix snake venom to activate Protein C; rate of hydrolysis of chromogenic substrate pNAPEP 1566TI measured at 405 nm; signal proportional to Protein C level. Antithrombin assay is a kinetic competition assay; heparin-antithrombin complex inhibits Factor Xa; residual Factor Xa hydrolyzes chromogenic substrate; pNA release measured at 405 nm; signal inversely proportional to antithrombin level. Devices are used in clinical laboratory settings by trained personnel. Results assist clinicians in evaluating coagulation status. This submission represents a name and manufacturer change for previously cleared devices; no changes to reagents, formulation, or performance characteristics.

Clinical Evidence

No new clinical data provided. Performance characteristics were established in original 510(k) submissions K023990 and K023991. The manufacturer confirms no product changes have occurred since original clearance.

Technological Characteristics

Chromogenic assays. Protein C assay: synthetic substrate, snake venom activator. Antithrombin assay: synthetic substrate, Factor Xa, Tris Heparin buffer. Detection via spectrophotometry at 405 nm. Quantitative measurement based on kinetic hydrolysis rates.

Indications for Use

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

Predicate Devices

• Chromocheck Protein C (K023990)
• Chromocheck Antithrombin A T (K023991)

Submission Summary (Full Text)

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## Premarket Notification [510(k)] Summary

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 : K050498

- Horiba ABX Company: Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 20 Telephone: + (33) 4 67 14 15 17 Fax:
Contact Person: Tim Lawton ([e-mail])

Date Prepared: February 16th, 2005

#### (a) Device Name:

| Trade/Proprietary Name: | Chromopep PC 2.5 or Chromopep PC 5 |
|-------------------------|--------------------------------------------------|
| Common or Usual Name: | Protein C chromogenic assay |
| Device Class | Class II |
| Classification Name: | Test, Quantitative factor deficiency (§864.7290) |
| Product Code: | GCP |

#### (b) Device Name:

| Trade/Proprietary Name: | Chromopep AT 2.5 or Chromopep AT 5 |
|-------------------------|---------------------------------------|
| Common or Usual Name: | Antithrombin chromogenic assay |
| Device Class | Class II |
| Classification Name: | Antithrombin quantitation (§864.7060) |
| Product Code: | JBQ |

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#### Substantial Equivalence:

#### Chromopep PC

The Chromopep PC is substantially equivalent to the predicate device Chromocheck Protein C of Precision BioLogic (K023990).

#### Chromopep AT

The Chromopep AT is substantially equivalent to the predicate device Chromocheck Antithrombin A T of Precision BioLogic (K023991).

## Description:

Chromopep PC is a chromogenic assay consisting of a synthetic substrate and Protein C activator.

Chromopep AT is a chromogenic assay consisting of a synthetic substrate, Factor Xa, and a Tris Heparin Buffer.

## Intended Use :

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

Chromopep AT is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

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## Determination of substantial equivalence :

| Parameter | Predicate device: | Device: |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Chromocheck Protein C<br>(K023990) | Chromopep PC |
| Intended Use | Test, quantitative factor deficiency | Test, Quantitative factor deficiency |
| Analytes | Protein C activity | Protein C activity |
| Component<br>Reagent<br>Matrices | Reagent 1 : Protein C activator in a distilled<br>water matrix (0.65 IU)<br>Reagent 2 : Chromogenic substrate in a<br>distilled water matrix | Reagent 1 : Protein C activator in a<br>distilled water matrix (0.65 IU)<br>Reagent 2 : Chromogenic substrate in a<br>distilled water matrix |
| Format | Lyophilized | Lyophilized |
| Packaging | Chromocheck Protein C 25<br>4 x Protein C Activator (0.65IU)<br>4 x Substrate (4mg)<br>(Reconstituted volume - 2.5ml)<br><br>Chromocheck Protein C 50<br>4 x Protein C Activator (1.30IU)<br>4 x Substrate (8mg)<br>(Reconstituted volume - 5.0ml) | Chromopep PC 2.5<br>4 x Protein C Activator (0.65IU)<br>4 x Substrate (4mg)<br>(Reconstituted volume - 2.5ml)<br><br>Chromopep PC 5<br>4 x Protein C Activator (1.30IU)<br>4 x Substrate (8mg)<br>(Reconstituted volume - 5.0ml) |

Table I : Comparison between Predicate Device & Chromopep PC

Table II : Comparison between Predicate Device & Chromopep AT

・・

| Parameter | Predicate device: | Device: |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Chromocheck Antithrombin<br>(K023991) | Chromopep AT |
| Intended Use | Antithrombin quantitation | Antithrombin quantitation |
| Analytes | Antithrombin | Antithrombin |
| Component<br>Reagent<br>Matrices | Reagent 1 : Factor Xa - Bovine Factor Xa<br>in a Tris Heparin Buffer matrix<br>Reagent 2 : Chromogenic substrate in a<br>distilled water matrix<br>Reagent 3 : Tris Heparin Buffer | Reagent 1 : Factor Xa - Bovine Factor Xa<br>in a Tris Heparin Buffer matrix<br>Reagent 2 : Chromogenic substrate in a<br>distilled water matrix<br>Reagent 3 : Tris Heparin Buffer |
| Format | Lyophilized | Lyophilized |
| Packaging | Chromocheck Antithrombin 25<br>4 x Factor Xa (5µg)<br>4 x Substrate (3.75mg)<br>4 x 5mL Tris Heparin Buffer<br>Chromocheck Antithrombin 50<br>4 x Factor Xa (10µg)<br>4 x Substrate (7.5mg)<br>4 x 10mL Tris Heparin Buffer | Chromopep AT 2.5<br>4 x Factor Xa (5µg)<br>4 x Substrate (3.75mg)<br>4 x 5mL Tris Heparin Buffer<br>Chromopep AT 5<br>4 x Factor Xa (10µg)<br>4 x Substrate (7.5mg)<br>4 x 10mL Tris Heparin Buffer |

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## Conclusions :

:

Chromopep PC can be considered as substantially equivalent to Chromocheck Protein C.

Chromopep AT can be considered as substantially equivalent to Chromocheck Antithrombin.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Tim Lawton Horiba ABX Parc Euromédecine Rue du Caducée – BP 7290 34184 Montpellier cedex 4 FRANCE

k050448 Re:

Roso Fro Chromopep AT 2.5 or Chromopep AT 5 Regulation Number: 21 CFR § 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: II Product Code: GGP, JBQ Dated: September 2, 2005 Received: September 6, 2005

Dear Mr. Lawton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your occurrent the device is substantially equivalent (for the indications ferenced above and nave decembers and and marketed predicate devices marketed in interstate for use stated in the enclosure) to regarly manat date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Food and Food conninetee prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, devices fill have been reclasified in assess approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appen of the general controls provisions of the Act. The r ou may, therefore, market the do rees, color equirements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration.

SEP 2 3 2005

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (soc abor of the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations wit may be subject to such additional connecess (CFR), Parts 800 to 895. In addition, FDA be found in This 21, 000vecements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please oc advised that I Dri 3 issuation of a complies with other requirements of the Act that FDA has made a determination administered by other Federal agencies. You must or ally receral statutes and regularems and iding, but not limited to: registration and listing (21 Comply with an the Are 3 requirements 801 and 809); and good manufacturing practice CrK Part 807), labelling (21 CF CF Rate 607), and 2007, and 2007, This letter requirenchts as set form in the quality as described in your Section 510(k) premarket will anow you to begin marketing your ence of your device to a legally marketed nonification. The I Driving of Sication for your device and thus, permits your device to proceed to the market.

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Page 2 --

If you desire specific information about the application of labeling requirements to your device, of In If you destic specific information and advertising of your device, please contact the Office of In
or questions on the promotion and advertising of your and and any and any a of questions on the promotion and Safety at [phone]. Also, please note the Vitto Diagliosite Device Devaluation and bareer to premarket notification" (21CFR Part \$07.97). regulation entitled, "Misoranang of responsibilities under the Act from the Act from the You may obtain other general information on your reposumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Robert Beckerh

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

Enclosure

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# Indications for Use

:

:

.

:

| 510(k) Number (if known): | K050448 |
|---------------------------|--------------|
| Device Name: | CHROMOPEP AT |

Indications For Use:

CHROMOPEP AT is intended for use as an *in vitro* chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.

| Prescription Use | <div> <span> ✓ </span> </div> | AND/OR | Over-The-Counter Use |
|-----------------------------|--------------------------------------------------------------------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off Divise of In Vitro Diagnostic Device
Office of In Vitro Diagnostic Device
Continues and Safety Office of in 11:24
Evaluation and Safety

510(k) K050448

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# Indications for Use

| 510(k) Number (if known): | K050448 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

CHROMOPEP PC is intended for use as an in vitro chromogenic assay for the Chritomor E. TO lo internation of Protein C activity in citrated human plasma.

Prescription Use ***\$\surd\$***

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dauphine Bautte

Division Sign-Off

Page 1 of

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050448

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