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 Description

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

AI/ML Overview

The provided text describes a 510(k) summary for the ACTICHROME® Heparin (anti-fIIa) assay. It focuses on demonstrating substantial equivalence to a predicate device, primarily through method comparison and precision studies.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for demonstrating substantial equivalence. Instead, it relies on a strong "positive correlation" with the predicate device and acceptable precision (CV%).

Performance Metric	Acceptance Criteria (Implied/General)	Reported Device Performance (ACTICHROME Heparin (anti-fIIa))
Method Comparison	Strong positive correlation (e.g., R-value > 0.9) and regression equation demonstrating agreement with predicate.	Lot 010 (N=88): R = 0.967, Y = 0.845X + 0.027
		Lot 010 (N=32): R = 0.917, Y = 0.764X + 0.032
		Sy.x (ng/ml) = 0.03 (N=88), 0.05 (N=32)
Intra-Assay Precision (CV%)	Low variability (e.g., typically <10% for clinical assays, depending on concentration)	Hepanorm Control 6: 4.7%
		Hepanorm Control 3: 10.8%
		Spiked Plasma (0.5 U/ml): 3.8%
		Spiked Plasma (0.25 U/ml): 9.5%
Inter-Assay Precision (CV%)	Low variability (e.g., typically <15% for clinical assays, depending on concentration)	Hepanorm Control 6: 7.6%
		Hepanorm Control 3: 9.6%
		Spiked Plasma (0.5 U/ml): 8.5%
		Spiked Plasma (0.25 U/ml): 9.4%

Study Proving Device Meets Criteria:

The studies described in the "Summary of Performance Data" are intended to prove the device meets these (implied) substantial equivalence criteria. These include:

Method Comparison Study: Compared the ACTICHROME Heparin (anti-fIIa) assay results against the predicate device (Spectrolyse® Heparin (anti-IIa)).
Precision Studies: Evaluated intra-assay and inter-assay variability using control samples.

2. Sample Size Used for the Test Set and Data Provenance:

Method Comparison Test Set:
- Sample Sizes: 88 samples (first regression) and 32 samples (second regression). It's unclear if these are independent sets or subsets.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "human plasma," which implies the samples were derived from human subjects. The fact that the studies were performed as part of a 510(k) submission prior to market launch suggests they were prospective in nature for validation purposes.
Precision Test Set:
- Hepanorm Controls: N=80 per control (for intra-assay and inter-assay with 20 runs).
- Spiked Plasma Controls: N=40 per control (for intra-assay and inter-assay with 10 runs).
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. Given the nature of precision studies for assay validation, these would typically be performed prospectively in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative determination. The "ground truth" for method comparison is the measurement obtained from the predicate device, and for precision, it's the statistical variation around the measured value of control samples. There are no human experts involved in establishing a "ground truth" in the way radiologists or pathologists establish it for imaging or histology.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is an IVD assay, not a device requiring human interpretation adjudicated by experts. The "adjudication" is based on the comparison of quantitative results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging or screening devices where human readers interpret results, and the impact of an AI algorithm on their performance is evaluated. The ACTICHROME Heparin (anti-fIIa) assay is a laboratory-based quantitative measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Yes, the studies presented are essentially "standalone" performance evaluations of the ACTICHROME Heparin (anti-fIIa) assay. The performance data (method comparison, precision) reflects the assay's output directly, without a human in the loop interpreting the result to reach a diagnosis or making a decision. The Electra 900C® (an analyzer) was used to determine the performance data, indicating automated measurement.

7. The Type of Ground Truth Used:

For Method Comparison: The "ground truth" for comparison was the results obtained from the predicate device, Spectrolyse® Heparin (anti-IIa). This is a form of reference method comparison.
For Precision: The "ground truth" implicitly used for evaluating precision are the expected values and inherent variability of the control samples themselves.

8. The Sample Size for the Training Set:

Not applicable. This document describes an IVD assay that is likely based on established chromogenic assay principles, rather than a machine learning model that requires a "training set" in the computational sense. The "development" of the assay likely involved optimizing reagents and protocols, but not training an algorithm on a 'dataset'.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the context of a machine learning algorithm. The development of the assay would have involved standard chemical and biological assay development practices, not machine learning ground truth establishment.

Summary

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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: 203 661-0000 203 661-7784 Fax:

Contact:

Clare Santulli Field Trial Coordinator Phone: 203 661-0000

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:

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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.

ACTICHROMEHeparin (anti-fIIa)	N	Regression Equation	R	Sy.x(ng/ml)	Sample Range(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

ACTICHROMEHeparin (anti-IIa)Lot 010	Mean(USP/ml)	Intra-AssayCV%	Inter-AssayCV%
Hepanorm Control 6	0.42	4.7	7.6
Hepanorm Control 3	0.23	10.8	9.6

Table 2a: Precision N=40

ACTICHROMEHeparin (anti-IIa) Lot 010	Mean(USP/ml)	Intra-AssayCV%	Inter-AssayCV%
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Regulation Number and Section

§ 864.7525 Heparin assay.

(a)
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).(b)
Classification. Class II (performance standards).