For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and GENT on VITROS Chemistry Systems.

Device Description

The VITROS Chemistry Products GENT Reagent. VITROS Chemistry Products Calibrator Kit 13, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS GENT assay. VITROS Chemistry Products GENT Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure gentamicin. VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately. VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters. VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

AI/ML Overview

This document describes the VITROS Chemistry Products GENT Reagent, VITROS Chemistry Products Calibrator Kit 13, and VITROS Chemistry Products TDM Performance Verifiers I, II, and III used to quantitatively measure gentamicin (GENT) concentrations.

1. Table of Acceptance Criteria and Reported Device Performance

The device is considered substantially equivalent to the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) based on the correlation and analytical performance studies. The primary acceptance criterion for the GENT assay is its strong correlation with the predicate device.

Device Characteristic	Acceptance Criteria (Predicate)	Reported Device Performance (New Device)
Intended Use	Quantitative measurement of gentamicin	Quantitative measurement of gentamicin
Basic principle	Homogeneous enzyme immunoassay	Homogeneous enzyme immunoassay
Reportable Range	0.25 - 10 µg/mL	0.6 - 10 µg/mL
Reagents	Liquid ready to use	Liquid ready to use
Instrumentation	SYVA-30R Biochemical System	VITROS 5,1 FS Chemistry System
Sample type	Serum and plasma	Serum and plasma
Correlation	Not explicitly stated as a numerical AC, but implied strong correlation is required	Linear regression: VITROS GENT assay = 1.00 X - 0.0138 ug/mL, with a correlation coefficient of 0.993 (where X is the predicate device)

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

The document states that "patient samples" were used for the equivalence study. However, the exact sample size of the test set is not specified.
The data provenance (e.g., country of origin, retrospective or prospective) is not specified in the provided text.

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

This information is not provided in the document. For in-vitro diagnostic devices like this, the "ground truth" is typically established by comparative analysis with an established, legally marketed predicate device, or by reference methods, rather than expert consensus on patient images or clinical assessments.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation involves comparing quantitative measurements from the new device against a predicate device, rather than expert adjudication of qualitative judgments.

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

A MRMC comparative effectiveness study was not performed as this device is an in-vitro diagnostic assay, not an imaging device that would typically involve human readers interpreting results. The comparison is between the new assay and a predicate assay.

6. Standalone (Algorithm Only) Performance Study

This description refers to the device's performance as a standalone assay. The study cited (correlation with predicate device, precision, expected values, linearity, and specificity studies) falls under this category of standalone analytical performance. The device is designed to operate autonomously with the VITROS 5,1 FS Chemistry System.

7. Type of Ground Truth Used

The ground truth for the equivalence study was established by the measurements obtained from the predicate device (SYVA® Emit® 2000 Gentamicin Plus Assay) using the same "patient samples." Additionally, the product's instructions for use refer to studies on precision, expected values, linearity, and specificity, which would use established analytical methods or reference materials to determine ground truth.

8. Sample Size for the Training Set

This document describes a 510(k) submission for an in-vitro diagnostic assay, not an AI/ML-driven device that typically requires a distinct "training set." Therefore, information regarding a specific training set size is not applicable and not provided. The development process for such assays involves internal studies (e.g., reagent optimization, calibration curve development) that are not typically referred to as "training sets" in the context of these submissions.

9. How Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" with ground truth in the AI/ML sense is not applicable to this type of device and submission. The analytical performance (e.g., linearity, precision) is established through rigorous laboratory experiments using reference materials and spiked samples with known concentrations, or comparison to established methods.

Summary

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JAN - 6 2005

1.0 510(k) Summary

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.

The assigned 510(k) number is: K042479

1.1 Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3482 Fax: (585) 453-3368

Contact Person: Carey A. Mayo, M.S., RAC

1.2 Date of Preparation: September 9, 2004

1.3 Device Proprietary Name(s)

Trade Name(s): VITROS Chemistry Products GENT Reagent VITROS Chemistry Products Calibrator Kit 13 VITROS Chemistry Products TDM Performance Verifier I, II, and III

Common Name(s): Gentamicin assay and controls

1.4 Classification Name(s)

Gentamicin Test System: Class II (21 CFR 862.3450) Calibrators: Class II (21 CFR 862.3200) Assayed Controls: Class I (21 CFR 862. 3280)

1.5 Predicate device

The VITROS Chemistry Products GENT reagent and calibrators are substantially equivalent to the SYVA® Emit® 2000 Gentamicin Plus Assay and Gentamicin Plus Calibrators (Dade Behring, Inc.).

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The VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the VITROS Chemistry Products TDM Performance Verifiers currently in commercial distribution.

1.6 Device description

VITROS Chemistry Products Calibrator Kit 13 and TDM Performance Verifiers are packaged and sold separately.

VITROS Chemistry Products Calibrator Kit 13 is a liquid ready to use calibrator set for gentamicin. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.

VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assayed values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

Device intended use(s) 1.7

VITROS Chemistry Products GENT Reagent: For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

VITROS Chemistry Products Calibrator Kit 13: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5.1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).

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VITROS Chemistry Products TDM Performance Verifier I, II and III: For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and GENT on VITROS Chemistry Systems.

1.8 Comparison to predicate device: Reagent and Calibrators

The VITROS Chemistry Products GENT Reagent and VITROS Chemistry Products Calibrator Kit 13 and are substantially equivalent to the SYVA Emit 2000 Gentamicin Plus Assay and the SYVA Emit 2000 Gentamicin Plus Calibrators, which were cleared by FDA (K962519) for IVD use.

The relationship between the VITROS GENT assay and the predicate device, determined by least squares linear regression, is:

VITROS GENT assay = 1.00 X - 0.0138 ug/mL, with a correlation coefficient of 0.993, where X is the predicate device.

In addition to the correlation studies, studies were performed to determine the precision, expected values, linearity, and specificity of the VITROS GENT assay (refer to the VITROS Chemistry Products GENT Reagent Instructions for Use for summaries of the results of these studies).

The table below lists the characteristics of the VITROS Chemistry Products GENT assay and the predicate device.

DeviceCharacteristic	VITROS GENT Assay(New device)	SYVA Emit 2000 Gentamicin PlusAssay (Predicate device)
Intended Use	Quantitative measurement ofgentamicin	Quantitative measurement ofgentamicin
Basic principle	Homogeneous enzymeimmunoassay	Homogeneous enzyme immunoassay
ReportableRange	0.6 - 10 µg/mL	0.25 - 10 µg/mL
Reagents	Liquid ready to use	Liquid ready to use
Instrumentation	VITROS 5,1 FS ChemistrySystem	SYVA-30R Biochemical System
Sample type	Serum and plasma	Serum and plasma

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Comparison to predicate device: Performance Verifiers 1.9

The VITROS Chemistry Products TDM Performance Verifiers are identical in intended use, base matrix, storage and handling and instructions for use as the previously cleared VITROS Chemistry Products TDM Performance Verifiers (K042476). The labeling will be updated to add assigned values for gentamicin so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products GENT assay.

1.10 Conclusions

The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products GENT reagent, VITROS Chemistry Products Calibrator Kits 13 and the VITROS Chemistry Products TDM Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. Equivalence to the predicates was demonstrated using a commercially available assay along with patient samples.

VITROS Chemistry Products GENT assay and Controls Ortho-Clinical Diagnostics, Inc.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 6 2005

Ms. Carey A. Mayo, M.S., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626-5101

Re: K042479

Trade/Device Name: VITROS Chemistry Products GENT Reagent VITROS Chemistry Products Calibrator Kit 13 VITROS Chemistry Products TDM Performance Verifiers I, II, and III Regulation Number: 21 CFR 862.3450

Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD, DLJ, DIF Dated: December 7, 2004 Received: December 8, 2004

Dear Ms. Mayo:

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. Iisting 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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Page 2 –

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 (240)276-0484. 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/industry/support/index.html

Sincerely yours,

Carelia B. Looks

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K042479 510(k) Number (if known):

Device Name:

Indications for Use:

1. VITROS Chemistry Products GENT Reagent
1. VITROS Chemistry Products Calibrator Kit 13
1. VITROS Chemistry Products TDM Performance Verifiers I, II, and III

For in vitro diagnostic use only. VITROS Chemistry Products GENT Reagent is used to quantitatively measure gentamicin (GENT) concentration in human serum and plasma. Serum or plasma gentamicin measurements are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

1. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 13 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of gentamicin (GENT).
1. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and GENT on VITROS Chemistry Systems.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k: K042479

VITROS Chemistry Products GENT assay and Controls Ortho-Clinical Diagnostics, Inc.

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Regulation Number and Section

§ 862.3450 Gentamicin test system.

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