The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Device Description

Serum or plasma is mixed with Reagent 1, which contains vancomycin labeled with the enzyme glucose-6-phosphate dehydrogenase (G6)DH). Subsequently, Reagent 2, which contains antibodies to vancomvcin and the coenzyme nicotinamide adenine dinucleotide (NAD), is added. Vancomycin in the sample and vancomycin-labeled G6PDH compete for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the vancomycin concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized NAD to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Dade Behring Inc. Emit® 2000 Vancomycin Assay, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Correlation	0.99
Slope	0.96
Intercept	-0.12 µg/dL

Note: The acceptance criteria themselves are implied by the comparison to the predicate device. The stated performance metrics of the Emit® 2000 Vancomycin Assay in comparison to the predicate exceed typical internal acceptance thresholds for linearity and correlation in quantitative assays (e.g., correlation coefficient often expected to be >0.95 or >0.98, slope close to 1, and intercept close to 0).

Study Details

Sample Size used for the test set and the data provenance:
- Sample Size: 100 patient samples
- Data Provenance: Not explicitly stated, but the context of "patient samples" implies human biological samples. It's retrospective as it's a split sample comparison to an existing predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The ground truth for this type of assay comparison is established by the measurements obtained from the predicate device (Emit® Vancomycin Assay, K881040), which itself would have undergone its own validation.
Adjudication method for the test set:
- Not applicable. This is a technical comparison of an in-vitro diagnostic device's quantitative output against a predicate device, not a diagnostic decision based on expert review.
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:
- Not applicable. This is not an AI-assisted diagnostic imaging or interpretation device. It's a quantitative chemical assay.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This study is a standalone performance evaluation of the Emit® 2000 Vancomycin Assay directly compared to a legally marketed predicate device. The assay itself operates without human intervention in the result generation, only in sample preparation and loading.
The type of ground truth used:
- The ground truth for this comparison study was established by the measurements obtained from the predicate device (Emit® Vancomycin Assay, K881040). The predicate device's performance characteristics served as the reference standard. The samples ranged from 5 to 50 µg/dL.
The sample size for the training set:
- Information on a separate "training set" is not provided as this is a traditional chemical assay validation for substantial equivalence, not a machine learning model. The development of the assay itself would have involved extensive R&D and optimization, but those details are not part of this 510(k) summary.
How the ground truth for the training set was established:
- Not applicable, as a distinct training set (in the context of machine learning) is not described. The assay's analytical performance is based on its chemical and enzymatic reactions, which were developed and characterized to accurately measure vancomycin concentration.

Summary

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KC020692

Dade Behring Inc. Emit® 2000 Vancomycin Assay 510(k) Notification

Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name:	Donna A. WolfDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	March 1, 2002
Name of Product:	Emit® 2000 Vancomycin Assay
FDA Classification Name:	Vancomycin Test System
Predicate Device:	Emit® Vancomycin Assay (K881040)

Device Description:

Intended Use: The Emit® 2000 Vancomycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of vancomycin in human serum or plasma. Measurements obtained are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Comparison to Predicate Device:

Conclusion: Split sample comparison between the Emit® 2000 Vancomycin Assay (modified) and the Emit® Vancomycin assay (K881040) gave a correlation coefficient of 0.99, slope of 0.96, and an intercept of -0.12 µg/dL when tested with 100 patient samples ranging from 5 to 50 µg/dL.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 0 2002

Ms. Donna A. Wolf Sr. Regulatory Affairs Specialist Dade Behring Inc. 514 GBC Drive Newark, DE 19702

Re: K020692

Trade/Device Name: Emit® 2000 Vancomycin Assay Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: March 1, 2002 Received: March 4, 2002

Dear Ms. Wolf:

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 1 additionally 809.10 for 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 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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Dade Behring Inc. Emit® 2000 Vancomycin Assay 510(k) Notification

Indications For Use Statement

Device Name: Emit® 2000 Vancomycin Assay

Indications for Use:

Sean Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number. K020692

(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

§ 862.3950 Vancomycin test system.

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