The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

Device Description

The IMMAGE Immunochemistry System AT3 Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Antithrombin III concentrations on Beckman's IMMAGE Immunochemistry System.

AI/ML Overview

The provided document describes the IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent. The acceptance criteria and supporting study details are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device (Array System Antithrombin III (AT3) Reagent) as the acceptance criteria for the IMMAGE System AT3 Reagent. The key performance metrics evaluated are method comparison (correlation with the predicate), stability, and imprecision.

Acceptance Criteria Category	Specific Metric	Predicate Performance (Implicit Acceptance)	Reported Device Performance (IMMAGE AT3 Reagent)
Method Comparison	Correlation (r)	High correlation with established methods	0.996 (vs. Array 360 System AT3 Reagent)
	Slope	Close to 1.0	1.088
	Intercept	Close to 0.0	-0.10
Stability	Shelf-life	Established, reliable shelf-life	24 months shelf-life
	Open Container Stability	Established, reliable open container stability	14 day open container stability
	Calibration Stability	Established, reliable calibration stability	14 day calibration stability
Imprecision	Within-Run Imprecision	Low imprecision	"Estimated Imprecision" (details not provided in table, but study was done)

2. Sample Size for the Test Set and Data Provenance

Sample Size: N = 136 for the method comparison study.
Data Provenance: The document does not explicitly state the country of origin. It is a retrospective study as it compares the new device's results to an existing, commercially available predicate device using collected samples. The "plasma" sample type is mentioned.

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

This device is an in-vitro diagnostic (IVD) for quantitative determination of Antithrombin III. The "ground truth" for such devices is typically established through direct measurement on samples where the analyte concentration is known or determined by a well-established, often reference, method.

Number of Experts: Not applicable in the context of expert consensus for image review or clinical diagnosis. The ground truth for the method comparison was established by the predicate device (Array 360 System AT3 Reagent), which itself is a laboratory instrument.
Qualifications of Experts: Not applicable. The "ground truth" here is the measurement from the predicate device.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is typically relevant for studies where human interpretation of medical images or clinical data is involved and discrepancies between readers need to be resolved. For an IVD device like the IMMAGE AT3 Reagent, the "adjudication" is essentially the statistical comparison of the new device's output against the predicate device's output. There is no mention of a human adjudication process for resolving discordant results between the IMMAGE system and the Array system; rather, a statistical correlation (regression analysis) is performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. This type of study is not applicable for this device. MRMC studies are designed to assess diagnostic performance with and without AI assistance for human readers, typically in image interpretation. The IMMAGE AT3 Reagent is an automated in-vitro diagnostic system that quantifies a biomarker, not an imaging device or an AI assistant for human interpretation.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

Was a standalone study done? Yes. The performance data presented (method comparison, stability, imprecision) appears to be for the IMMAGE AT3 Reagent operating as a standalone system (algorithm only) without direct human-in-the-loop diagnostic interpretation that would alter its output. The system measures Antithrombin III concentrations, and its accuracy is assessed against a predicate device.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance evaluation (method comparison) was established by the results obtained from a legally marketed predicate device: the Array 360 System AT3 Reagent. This is a form of "reference method" in the context of IVD devices for quantitative analytes.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. This device, being an immunochemistry system, likely relies on established biochemical reaction principles and calibration curves rather than machine learning algorithms trained on large datasets. Therefore:

Sample Size for Training Set: Not applicable or not specified, as the device doesn't appear to be based on an AI/ML model requiring a training set in the conventional sense. Its performance is validated through analytical studies (method comparison, stability, imprecision).

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

As noted above, the concept of a "training set" with ground truth in the AI/ML context doesn't appear to apply directly to this device. The system's operation is based on rate nephelometry and calibrated using a specific calibrator (Beckman Calibrator 2). The establishment of the calibrator values would involve a separate, rigorous process, likely traceable to a reference standard, but this is distinct from establishing ground truth for an AI training set.

Summary

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DEC 2 4 1997

Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

1.0 Submitted By:

Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457

2.0 Date Submitted:

October 30, 1997

3.0 Device Name(s):

3.1 Proprietary Names

IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

Classification Name 3.2

Antithrombin III assay (21 CFR § 864.7060)

4.0 Predicate Device(s):

IMMAGE SystemReagent	Predicate	Manufacturer	DocketNumber
IMMAGE SystemAntithrombin III (AT3)	Array SystemsAntithrombin III(AT3)	Beckman Instruments,Inc.	K901977

5.0 Description:

6.0 Intended Use:

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Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

Reagent	Aspect/Characteristic	Comments
SIMILARITIES
IMMAGE System AT3 Reagent	Analytic Range	Same asBeckman Antithrombin III reagent
	Nephelometric methodology
	Antibody source (goat)
DIFFERENCES
IMMAGE System AT3 Reagent	Buffer/Reagent volumes	IMMAGE System uses half of thevolumes than are utilized by the ArraySystem for AT3.
	Antibody concentration	IMMAGE AT3 has a higher antibodyconcentration than the BeckmanAntithrombin III reagent

Summary of Performance Data: 8.0

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate results obtained from the Beckman Reagent on the Array® 360 System to the IMMAGE System Reagent.

Method Comparison Study Results IMMAGE Antithrombin III (AT3) Reagent

Analyte	SampleType	Slope	Intercept	r	n	Predicate Method
IMMAGE AT3Reagent	plasma	1.088	-0.10	0.996	136	Array 360 SystemAT3 Reagent

Stability Study Results

Reagent	Product Claim
IMMAGE AT3	24 month shelf-life14 day open container stability14 day calibration stability

Estimated Imprecision

. Fall . Fall 24 . 1 . 1 . 1.STATIST AND CHARACT FOR THE FOR THE FITT	SELECTRES ENRESERSEMENT FREEDE		.111 FA 1 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8
		Within-Run Imprecision


evel 3LANT OR BOOK IL AN OR LEAR LEAR LEASE OF CHARACT CHA

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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510(k) Number (if known):

Device Name: IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

Indications for Use:

21 CFR 864.7060 Antithrombin III assay

(a) Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coaqulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

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

L.M. Cesark of the Air Marong

Division Sign-O Division of Clinical Laboratory Devices 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-the-Counter Use Optional Format 1-2-96

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2 1 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Annette Hellie · Senior Requlatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 92822-8000 Brea, California

Re : K974110 IMAGE™ System Antithrombin III (AT3) Reagent Requlatory Class: II Product Code: DDQ, JBQ Dated: December 11, 1997 Received: December 12, 1997

Dear Ms. Hellie:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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 marroos process 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 (301) 594-4588. Additionally, for questions on compreadios 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 the regulation chercred, "Mibranding by 10ther general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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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of page

510(k) Number (if known):

Device Name: IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent

Indications for Use:

21 CFR 864.7060 Antithrombin III assay

(a) Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
---------------------	--

Division of Clinical Laboratory Devices

510(k) Number	K974110
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Prescription Use (per 21 CFR 801.109)

్రాఫ్ట్

Over-the-Counter Use Optional Format 1-2-96

Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).