ACTICHROME HEPARIN (ANTI-FIIA)

K013637 · American Diagnostica, Inc. · KFF · Apr 16, 2002 · Hematology

Device Facts

• Record ID: K013637
• Device Name: ACTICHROME HEPARIN (ANTI-FIIA)
• Applicant: American Diagnostica, Inc.
• Product Code: KFF · Hematology
• Decision Date: Apr 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7525
• Device Class: Class 2

Indications for Use

ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

Device Story

ACTICHROME Heparin (anti-fIIa) is a chromogenic assay for quantifying therapeutic heparin in human plasma. The device measures factor IIa (thrombin) inhibition to determine heparin levels. It is intended for in vitro diagnostic use in clinical laboratory settings. Healthcare providers use the quantitative output to monitor heparin therapy. The assay performance was validated using the Electra 900C analyzer.

Clinical Evidence

Bench testing only. Method comparison study (N=120 total) against predicate device showed positive correlation (R=0.917-0.967). Precision studies evaluated intra-assay and inter-assay variability across multiple runs (N=80 and N=40 per control), with CVs ranging from 3.8% to 10.8%.

Technological Characteristics

Chromogenic assay for factor IIa inhibition. In vitro diagnostic reagent kit. Quantitative measurement performed on automated clinical laboratory instrumentation (e.g., Electra 900C).

Indications for Use

Indicated for the quantitative determination of therapeutic heparin in human plasma via factor IIa (thrombin) inhibition measurement. 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 (anti-IIa) (K972209)

Submission Summary (Full Text)

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# APR 1 6 2002

#### Section 3

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ACTICHROME® Heparin (anti-fIIa) 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: K013637

#### Submitted by:

American Diagnostica Inc. 222 Railroad Avenue Greenwich, CT 06830 Phone: [phone] 661-7784 Fax:

#### Contact:

Clare Santulli Field Trial Coordinator Phone: [phone]

#### Summary Revised

March 21, 2002

#### Name of the Device:

ACTICHROME® Heparin (anti-fIIa) Product No. 820

#### Classification:

864.7525 Heparin Assay, Class II Product Code KFF

#### Predicate Device:

Spectrolyse® Heparin (anti-IIa) K972209

#### Intended Use:

ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data.

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#### Summary of Substantial Equivalence:

ACTICHROME Heparin (anti-flla) kit is substantially equivalent to the commercially available predicate device, Spectrolyse® Heparin (anti-IIa), 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 one lot of ACTICHROME Heparin (anti-fila). The regression statistics in Table 1 indicate a positive correlation between the ACTICHROME Heparin (anti-flla) assay and the predicate device.

| ACTICHROME<br>Heparin (anti-fIIa) | N | Regression Equation | R | Sy.x<br>(ng/ml) | Sample Range<br>(ng/ml) |
|-----------------------------------|----|---------------------|-------|-----------------|-------------------------|
| Lot 010 | 88 | $Y=0.845X+.027$ | 0.967 | 0.03 | 0.02-0.71 |
| Lot 010 | 32 | $Y=0.764X+.032$ | 0.917 | 0.05 | 0.00-0.55 |

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

#### Precision

Precision studies evaluated intra-assay and inter-assay variability with 2 control samples run in replicates of 4 over 20 runs (N=80 per control) and with two control samples run in replicates of 4 over 10 runs (N=40 per control), respectively.

#### Table 2a: Precision N=80

| ACTICHROME<br>Heparin (anti-IIa)<br>Lot 010 | Mean<br>(USP/ml) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
|---------------------------------------------|------------------|--------------------|--------------------|
| Hepanorm Control 6 | 0.42 | 4.7 | 7.6 |
| Hepanorm Control 3 | 0.23 | 10.8 | 9.6 |

## Table 2a: Precision N=40

| ACTICHROME<br>Heparin (anti-IIa) Lot 010 | Mean<br>(USP/ml) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
|----------------------------------------------|------------------|--------------------|--------------------|
| Control Plasma spiked with 0.5 U/ml Heparin | 0.51 | 3.8 | 8.5 |
| Control Plasma spiked with 0.25 U/ml Heparin | 0.23 | 9.5 | 9.4 |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 1 6 2002

Mr. John B. Berryman Director of Regulatory Affairs American Diagnostics Inc. 222 Railroad Avenue Greenwich, Connecticut 06830

Re: k013637

> Trade/Device Name: ACTICHROME® Heparin Assay (anti-fIIa) Regulation Number: 21 CFR § 864.7525 Regulation Name: Heparin Assay Regulatory Class: II Product Code: KFF Dated: March 22, 2002 Received: March 25, 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 (OS) 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed nvedicate device results in a classification 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 11 you doshe open in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of 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 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 Autman

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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510(k) Notification

Section 2

### STATEMENT OF INDICATIONS FOR USE

Applicant: ___________________________________________________________________________________________________________________________________________________________________

510(k) Number: K013637

Device:

#### Indications for Use:

ACTICHROME® Heparin (anti-flia) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 9000 was used to determine performance data.

This kit is for in vitro diagnostic use.

Josephine Bautista

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number.

Concurrence of CDRH, Office of Device Evaluation (ODE)