The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

Device Description

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles, Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

AI/ML Overview

This document does not contain the detailed information necessary to fully answer all aspects of your request. The provided text is a 510(k) summary for a medical device, which primarily focuses on establishing substantial equivalence to a predicate device rather than providing a comprehensive study report with acceptance criteria and detailed performance data.

Here's an analysis of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. A 510(k) summary typically references that performance characteristics are similar to the predicate device but does not usually include a table of specific acceptance criteria and the detailed results of a new study against those criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document. The summary states "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device," implying that new, extensive clinical studies for this specific modification were not deemed necessary for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided document. The device is an in vitro diagnostic for quantitative analysis of quinidine. The "ground truth" for such devices is typically established through a reference measurement method or certified calibrators, not through human expert consensus in the same way an imaging device might use a radiologist.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document. As a quantitative immunoassay, adjudication by human experts in the described manner is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable to this device. The Emit® 2000 Quinidine Assay is an automated in vitro diagnostic immunoassay for quantitative analysis, not an AI-assisted diagnostic imaging or human-read system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not explicitly detailed in the document as a "standalone study." However, the device itself is a standalone quantitative assay. It functions as an algorithm (the immunoassay process) providing a numerical result, without requiring human interpretation of complex patterns, thus not fitting the typical "algorithm only without human-in-the-loop performance" in the context of imaging or AI. Performance characteristics for such an assay would typically include precision, accuracy, linearity, and interference studies. The summary implies these are "the same... performance characteristics" as the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for a quantitative diagnostic assay like this is typically established by comparing results to a reference method (e.g., GC-MS, LC-MS/MS) or by using certified reference materials/calibrators with known concentrations. The document does not specify the exact method used for the original predicate device or for validating this modified version.

8. The sample size for the training set

This is not applicable and not present in the document. This device is an immunoassay, not a machine learning or AI-based device that requires a "training set" in the conventional sense. The "training" for such a system would involve optimizing assay reagents and conditions, which is part of its manufacturing and design, not typically reported as a "training set" size in a 510(k) summary.

9. How the ground truth for the training set was established

This is not applicable and not present for the reasons stated in point 8.

Summary of Device and Study (as far as discernible from the document):

Device Name: Emit® 2000 Quinidine Assay
Intended Use: Quantitative analysis of quinidine in human serum or plasma for diagnosis/treatment of overdose or monitoring therapy.
Device Description: Homogeneous enzyme immunoassay. The modification described in this 510(k) pertains to minor packaging differences (smaller fill volume, different shaped bottles, barcode label) and compatibility with specific OLYMPUS® analyzers, while the assay chemistry and performance are stated to be "the same" as the predicate.
Study: This 510(k) filing primarily relies on demonstrating substantial equivalence to a predicate device (the original Emit® 2000 Quinidine Assay). No detailed new performance study data for this specific packaging modification is provided in the summary. The assertion is that "The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, the "study" for this 510(k) seems to be a demonstration that the changes do not affect the established performance characteristics.

Summary

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JUN 1 2 2001

KO11605

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS For Emit® 2000 Quinidine Assay

1. Manufacturer and Contact Information:

Manufacturer:

Syva Company - Dade Behring Inc. 20400 Mariani Ave. Cupertino, CA 95014

Contact Information:

Susan L. Collins Requiatory Affairs Syva Company - Dade Behring, Inc. 3403 Yerba Buena Road San Jose, CA 95135 Tel: 408 - 239 - 4412 Fax: 408 - 239 - 2348

1. Date Summary Prepared: May 22, 2001
1. Device Trade Name: Emit® 2000 Quinidine Assay
1. Common Name: Enzyme Immunoassay, Quinidine

5. Device Classification Name:

The Clinical Chemistry and Clinical Toxicology Devices Panel have classified "Quinidine test system" as Class II, 21 CFR Part 862.3320.

6. Intended Use:

The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

7. Device Description:

8. Substantial Equivalence

The modified device has the same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device. In conclusion the modified Emit® 2000 Quinidine Assay is substantially equivalent to the predicate Emit® 2000 Quinidine Assay.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

JUN 1 2 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Susan L. Collins Regulatory Affairs Syva Company-Dade Behring Inc. 3403 Yerba Buena Road San Jose, CA 95135

510(k) Number: K011605 Re: Trade/Device Name: Emit® 2000 Quinidine Assay Regulation Number: 862.3320 Regulatory Class: II Product Code: LBZ Dated: May 22, 2001 Received: May 24, 2001

Dear Ms. Collins:

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 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will anow you to organizatial equivalence of your device to a legally marketed noutication. The I D7X Incing of backing 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 additionally 607.10 for in This alagitestions on the promotion and advertising of your device, (201) 594-4566. Frauncently, at (301) 594-4639. Also, please note the regulation prease condor and office creference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionitation on your responsibility the number (800) 638-2041 or (301) 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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Indications for Use Statement

Device Name: Emit® 2000 Quinidine Assay 510(k) Number (if known): KO11605

Indications for Use:

Fred Lacy

Division Sign-Off) Division of Clinical Laboratory Devices K011605 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)

Regulation Number and Section

§ 862.3320 Digoxin test system.

(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.