ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

K013318 · American Diagnostica, Inc. · KFF · Mar 8, 2002 · Hematology

Device Facts

• Record ID: K013318
• Device Name: ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
• Applicant: American Diagnostica, Inc.
• Product Code: KFF · Hematology
• Decision Date: Mar 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7525
• Device Class: Class 2

Indications for Use

ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

Device Story

Chromogenic assay for quantitative determination of unfractionated and low molecular weight heparins in human plasma; measures inhibition of factor Xa (fXa) activity. Used in clinical laboratory settings; performed by laboratory technicians. Input: human plasma samples. Output: quantitative heparin concentration levels. Results used by clinicians to monitor heparin therapy and adjust clinical decision-making. Performance data validated using Electra 900C analyzer.

Clinical Evidence

Bench testing only. Method comparison studies performed against predicate device using 92, 40, and 42 samples respectively. Correlation coefficients (R) ranged from 0.859 to 0.913. Precision evaluated via intra-assay and inter-assay variability; intra-assay CVs ranged 2.8-5.6%, inter-assay CVs ranged 4.1-10.6%.

Technological Characteristics

Chromogenic assay; in vitro diagnostic; quantitative measurement of fXa inhibition. Utilizes spectrophotometric analysis via automated analyzer (Electra 900C).

Indications for Use

Indicated for quantitative determination of unfractionated and low molecular weight heparins in human plasma for in vitro diagnostic use.

Regulatory Classification

Identification

A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

Predicate Devices

• Spectrolyse® Heparin (Xa) (K923499)

Submission Summary (Full Text)

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Section 3

8 2002 MAR

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ACTICHROME® Heparin (anti-fXa) Heparin Assay (per 21CFR864.7525)

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

The assigned 510(k) number is: K013318

## Submitted by:

American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: [phone] Fax: [phone]

### Contact:

Clare Santulli Field Trial Coordinator Phone: [phone]

## Summary Revised:

February 26, 2002

#### Name of the Device:

ACTICHROME® Heparin (anti-fXa) Product No. 832

#### Classification:

Heparin Assay, Class II 864.7525 Product Code KFF

## Predicate Device:

Spectrolyse® Heparin (Xa) K923499

#### Intended Use:

ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data.

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## Summary of Substantial Equivalence:

ACTICHROME Heparin (anti-fXa) kit is substantially equivalent to the commercially available ACTICHNOMIS Hopanin (and Tra) in Is ourin (Xa), manufactured by Biopool International, Ventura, CA, in performance and intended use.

## Summary of Performance Data:

### Method Comparison

Method comparison studies versus the predicate device were performed with two lots of ACTICHROME Heparin (anti-fXa). The regression statistics in Table 1 indicate a positive correlation between the ACTICHROME Heparin (anti-fXa) assay and the predicate device.

| ACTICHROME<br>Heparin (anti-fXa) | N | Regression Equation | R | Sy.x<br>(ng/ml) | Sample Range<br>(ng/ml) |
|----------------------------------|----|---------------------|-------|-----------------|-------------------------|
| Lot 007 (unfractionated Heparin) | 92 | $Y=0.843X+0.003$ | 0.913 | 0.07 | 0.01-0.8 |
| Lot 010 (unfractionated Heparin) | 40 | $Y=0.765X--0.009$ | 0.859 | 0.08 | 0.00-0.8 |
| Lot 010 (LMW Heparin) | 42 | $Y=1.363X--0.139$ | 0.895 | 0.14 | 0.30-1.3 |

Table 1: Correlation (Y= ACTICHROME, X= predicate device)

#### Precision

Lot 007 precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in quadruplicate over 20 runs (N = 80 per control). Lot 010 evaluated intra-assay and inter-assay variability with 2 control samples run in quadruplicate over 10 runs (N = 40 per control). Lot 010 evaluated unfractionated heparin and low molecular weight heparin. The results are provided in Tables 2a and 2b.

Table 2a: Precision using unfractionated heparin

| ACTICHROME<br>Heparin (anti-fXa)Lot 007 | Mean<br>(U/ml) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
|-----------------------------------------|----------------|--------------------|--------------------|
| Hepanorm Control 6 | 0.44 | 3.3 | 4.1 |
| Hepanorm Control 3 | 0.25 | 5.6 | 4.8 |

Table 2b: Precision using unfractionated heparin and low molecular weight heparin

| ACTICHROME<br>Heparin (anti-fXa) Lot 010 | | | |
|--------------------------------------------------|----------------|--------------------|--------------------|
| | Mean<br>(U/ml) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
| Control Plasma spiked with 0.5 U/ml UFH Heparin | 0.51 | 2.8 | 4.6 |
| Control Plasma spiked with 0.25 U/ml UFH Heparin | 0.22 | 3.6 | 10.6 |
| Control Plasma spiked with 0.5 U/ml LMW Heparin | 0.48 | 2.9 | 6.2 |
| Control Plasma spiked with 0.25 U/ml LMW Heparin | 0.24 | 5.1 | 9.3 |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 8 2002

Mr. John Berryman Director of Regulatory Affairs American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830

k013318 Re:

Trade/Device Name: ACTICHROME® Heparin (anti-fXa) Regulation Number: 21 CFR 864.7525 Regulation Name: Heparin assay Regulatory Class: Class II Product Code: KFF Dated: February 26, 2002 Received: February 27, 2002

Dear Mr. Berryman:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and in you all stantial equivalence of your device to a legally marketed noutheation. The I Dr I mining of exceion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 II you desire spoonly active diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in in the promotion and advertising of your device, [phone]. Traditional Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small nuoufacturers International and Consumer Assistance at its toll-free number [phone] or 1301) 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 2

## STATEMENT OF INDICATIONS FOR USE

Applicant: ___ American Diagnostica Inc.

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device: ACTICHROME® Heparin (anti-fXa) ____

#### Indications for Use:

ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data.

This kit is for in vitro diagnostic use.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Arphini Bautista

510(k) Number K01331