ACTICLOT PROTEIN S, MODEL 843L

K012386 · American Diagnostica, Inc. · GGP · Sep 14, 2001 · Hematology

Device Facts

• Record ID: K012386
• Device Name: ACTICLOT PROTEIN S, MODEL 843L
• Applicant: American Diagnostica, Inc.
• Product Code: GGP · Hematology
• Decision Date: Sep 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7290
• Device Class: Class 2

Intended Use

ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.

Device Story

ACTICLOT Protein S is an in vitro diagnostic clotting assay used in clinical laboratories to measure Protein S activity in human plasma samples. The device functions as a quantitative clotting assay; it processes plasma samples to determine activity levels, which are then used by clinicians to assess patients for congenital Protein S deficiencies or secondary conditions like liver disease or inflammation. Results assist in evaluating the risk of thromboembolism. The assay is performed by laboratory technicians; results are interpreted by healthcare providers to guide clinical decision-making regarding coagulation status.

Clinical Evidence

Bench testing only. Method comparison study performed with 115 samples (n=78 and n=37 across two lots) against the predicate device. Correlation coefficients (R) were 0.868 and 0.916. Precision studies conducted with 80 replicates per control level; intra-assay CVs were 2.3-3.0% and inter-assay CVs were 5.1-5.9%.

Technological Characteristics

In vitro diagnostic clotting assay. Quantitative measurement of Protein S activity in human plasma. Standard laboratory coagulation testing methodology.

Indications for Use

Indicated for quantitative determination of Protein S activity in human plasma. Used to identify low Protein S activity associated with congenital deficiencies (type I, IIa, IIb), pregnancy, liver disease, and inflammatory disease. Low activity is associated with increased risk of thromboembolism.

Predicate Devices

• BIOCLOT Protein S-300 ACT (K955738)

Submission Summary (Full Text)

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#### Section 3

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

ACTICLOT® Protein S Quantitative Factor Deficiency Test (per 21CFR864.7290)

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: K010386

#### Submitted by:

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

# Contact:

Clare Santulli Field Trial Coordinator Phone: [phone]

# Summary Prepared:

July 8, 2001

#### Name of the Device:

ACTICLOT Protein S Product # 843L

#### Classification Name(s):

Factor Deficiency Test, Class II 864.7290 81GGP Test, Qualitative and Quantitative Factor Deficient

# Predicate Device:

BIOCLOT Protein S-300 ACT K955738

#### Intended Use:

ACTICLOT Protein S is an in vitro diagnostic clotting assay for the quantitative determination of Protein S activity in human plasma.

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# Summary of Substantial Equivalence:

ACTICLOT Protein S is substantially equivalent to the commercially available predicate device (BIOCLOT Protein S-300 ACT, 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 different lots of ACTICLOT Protein S. The regression statistics in Table 1 indicate a positive correlation between the ACTICLOT assay and the predicate device.

| Table 1: Correlation (Y = ACTICLOT, X = predicate device) | | | | LE MARK STATUS STATE AND STATE A BEACH AND A BEACH AND A BREAK A BALL A BEA A BALL A BEA BE A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A BARRET A | |
|-----------------------------------------------------------|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
|-----------------------------------------------------------|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|

| ACTICLOT<br>Lot | n | Regression Equation | R | Sy.x<br>(% Activity) | Sample Range<br>(% Activity) |
|-----------------|----|---------------------|-------|----------------------|------------------------------|
| 1 | 78 | Y = 0.91X + 17.2 | 0.868 | 12.3 | 22-114 |
| 2 | 37 | Y = 1.06X - 7.5 | 0.916 | 14.2 | 18-117 |

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).

Table 2: Precision

| Control<br>Level | Mean<br>(% Activity) | Intra-Assay<br>CV% | Inter-Assay<br>CV% |
|------------------|----------------------|--------------------|--------------------|
| Normal | 86.8 | 3.0 | 5.9 |
| Abnormal | 41.9 | 2.3 | 5.1 |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# SEP 1 4 2001

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

Re: k012386

Trade/Device Name: ACTICLOT® Protein S Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency test Regulatory Class: Class II Product Code: GGP Dated: July 20, 2001 Received: July 27, 2001

# 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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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 predicate 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 ' additionally 809.10 for 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 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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510(k) Notification

Section 2

# STATEMENT OF INDICATIONS FOR USE

Applicant: __ American Diagnostica Inc. __

510(k) Number: _ Ko12386

Device:

# Indications for Use:

The ACTICLOT® Protein S clotting assay is an in vitro diagnostic device intended for the quantitative determination of Protein S activity in human plasma.

Protein S activity levels in plasma are known to be low in patients with congenital Protein S deficiencies type-I, type-IIb, and type-IIb, and may also be low in pregnant I fotom & donemelers with liver disease and in inflammatory disease in which levels of C4b wonline in patients with are elevated. A decrease in Protein S activity is associated with an increased incidence of thromboembolism.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Josephine Bautista

Owision/Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K012386