The CEDIA® Vancomycin Assay is a homogenous enzyme immunoassay intended for in vitro diagnostic use in the quantitative determination of vancomycin in human serum or plasma for the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.

Device Description

The CEDIA® Vancomycin Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment of B-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive 8-galactosidase fragments, and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.

AI/ML Overview

The provided text is a 510(k) summary for the CEDIA® Vancomycin Assay, a diagnostic device. It aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance acceptance criteria through a dedicated study with the information requested. Therefore, much of the requested information is not available in the provided document.

Here's an analysis based on the available information:

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

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics (like accuracy, precision, limits of detection). Instead, it focuses on demonstrating substantial equivalence to a predicate device based on intended use and physical properties.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (Summary of Equivalence)
Intended Use	Equivalent to predicate (quantitative determination of vancomycin in human serum/plasma for diagnosis/treatment of overdose and monitoring therapy)	The CEDIA® Vancomycin Assay has an identical intended use to the predicate device.
Analyte	Vancomycin	Vancomycin
Matrix	Serum or plasma	Serum or plasma
Calibrator Form	Not explicitly defined, but predicate uses liquid.	Liquid
Calibrator Levels	Not explicitly defined, but predicate uses 6 levels.	Two (2) Levels (0 and 50 µg/mL) - Note: This is a characteristic difference, but deemed substantially equivalent.
Storage	2°C to 8°C until expiration date	2°C to 8°C until expiration date
Stability	Until expiration date on vial label	Until expiration date on vial label and Package Insert for Kit and reconstituted reagents.
Principle of Use	Homogeneous enzyme immunoassay	Homogeneous enzyme immunoassay

The "study that proves the device meets the acceptance criteria" is implicitly the comparison to the predicate device (Abbott AxSYM® Vancomycin II, K955851). The 510(k) process relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials to establish de novo performance criteria. The summary states: "The information provided in this pre-market notification demonstrates that the CEDIA® Vancomycin Assay is substantially equivalent to the Abbott AxSYM® Vancomycin II assay, the previously cleared predicate device (K955851). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device."

2. Sample size used for the test set and the data provenance

The document does not provide specific details on a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically found in the more comprehensive study reports or validation data submitted to the FDA, which are not part of this 510(k) summary. The summary focuses on comparing the new device's characteristics and intended use to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. Given that this is an in vitro diagnostic (IVD) device for quantitative measurement, the "ground truth" would likely be established through reference methods (e.g., HPLC-MS) rather than expert consensus on images or interpretations.

4. Adjudication method for the test set

This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiology) to resolve discrepancies. For a quantitative IVD, the "adjudication" would be related to statistical analysis and agreement with reference methods.

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

An MRMC study is not applicable to this device. This is a quantitative immunoassay for vancomycin concentration, not an AI-assisted diagnostic imaging device requiring human readers or interpretation improvement.

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

This concept is not directly applicable in the typical sense for this type of IVD. The device itself performs the quantitative measurement. Its "standalone" performance would be its analytical performance (accuracy, precision, linearity, etc.), which would have been part of the validation studies submitted to the FDA but is not detailed in this 510(k) summary.

7. The type of ground truth used

The ground truth for a quantitative immunoassay like the CEDIA® Vancomycin Assay would typically be established by a reference method (e.g., liquid chromatography-mass spectrometry (LC-MS)) or well-characterized control samples with known vancomycin concentrations, rather than expert consensus, pathology, or outcomes data in the usual sense. The summary does not explicitly state the specific reference method used for validation studies.

8. The sample size for the training set

This information is not provided in the 510(k) summary. For an enzyme immunoassay, the "training set" would refer to samples used during the assay development and optimization phases to establish calibration curves, reagent formulations, and operating parameters. This is distinct from machine learning model training sets.

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

This information is not provided in the 510(k) summary. Similar to item 7, the ground truth for samples used in development and optimization would have been established by reference methods or gravimetric preparation of standards.

Summary

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K032811

SECTION II

510(k) SUMMARY

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

510(k) Number:

Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Preparation Date:

September 8, 2003

Device Information:

Device Classification Name:	Radioimmunoassay, Vancomycin
Common/Usual Name:	Vancomycin Immunoassay Test System
Proprietary Name:	CEDIA® Vancomycin Assay
Regulation Number:	21 CFR§862.3950
Regulatory Name:	Vancomycin tesystem
Product Code:	LEH
Regulatory Class:	Class II

Predicate Devices:

The CEDIA® Vancomycin Assay is substantially equivalent to the AxSYM® Vancomycin II (Abbott Diagnostics, Abbott Park, IL) (K955851) for its stated intended use.

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Device Description:

Intended Use:

Comparison to Predicate Device(s):

The CEDIA® Vancomycin Assay is substantially equivalent to the Abbott AxSYM® Vancomycin II (K955851) in its intended use and principle of use.

DeviceCharacteristics	Subject Device	Predicate Device(K955851)
Intended Use	The CEDIA® Vancomycin Assay is ahomogenous enzyme immunoassayintended for in vitro diagnostic use inthe quantitative determination ofvancomycin in human serum orplasma for the diagnosis and treatmentof vancomycin overdose and inmonitoring the level of vancomycin toensure appropriate therapy.	AxSYM® Vancomycin II (K955851)is a reagent system for the quatitativemeasurement of vancomycin, anantibiotic drug, in serum or plasma.The measurements obtained are usedin the diagnosis and treatment ofvancomycin overdose and inmonitoring levels of vancomycin toensure appropriate therapy.
Analyte	Vancomycin	Vancomycin
Matrix	Serum or plasma	Serum or plasma
Calibrator Form	Liquid	Liquid
Calibrator Levels	Two (2) Levels (0 and 50 µg/mL)	Six (6) Levels
Storage	2°C to 8°C until expiration date	2°C to 8°C until expiration date
Stability	Until expiration date noted on viallabel and Package Insert for Kit andreconstituted reagents.	Until expiration date noted on viallabel.

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Summary:

The information provided in this pre-market notification demonstrates that the CEDIA® Vancomycin Assay is substantially equivalent to the Abbott AxSYM® Vancomycin II assay, the previously cleared predicate device (K955851). Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available predicate device. The information supplied in this pre-market notification provides reasonable assurance that the CEDIA® Vancomycin Assay is safe and effective for its stated intended use.

CEDIA® is a registered trademark of Roche Diagnostics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles. The profiles and lines are arranged to resemble a bird in flight. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

NOV 2 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

David Casal, Ph.D. VP, Clinical, Regulatory and Quality Affairs Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538

Re: K032811

Trade/Device Name: CEDIA® Vancomycin Assay Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: September 8, 2003 Received: September 12, 2003

Dear Dr. Casal:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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SECTION III

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

CEDIA® Vancomycin Assay Device name:

Indications for Use:

Alberto Sutz

Division Sign-Off for Jean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032811

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ V

Over-the Counter Use

(per 21 CFR §801.109)

(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.