For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).
For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assaved control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.

Device Description

The VITROS Chemistry Products VANC Reagent, VITROS Chemistry Products Calibrator Kit 11, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VANC assay. VITROS Chemistry Products VANC Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure vancomycin.

VITROS Chemistry Products Calibrator Kit 11 and TDM Performance Verifiers are packaged and sold separately.

VITROS Chemistry Products Calibrator Kit 11 is a liquid ready to use calibrator set for vancomycin. 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 liguid 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

Here's an analysis of the provided 510(k) summary regarding the VITROS Chemistry Products VANC assay and controls:

1. Acceptance Criteria and Reported Device Performance

The submission uses substantial equivalence to a predicate device as its basis for clearance, rather than defining explicit acceptance criteria with pre-specified thresholds for performance metrics. The primary "acceptance criteria" here are implied by the performance of the predicate device and the demonstration of equivalent performance for the new device.

Metric / Characteristic	Acceptance Criteria (Implied by Predicate)	Reported VITROS VANC Assay Performance
Intended Use	Quantitative measurement of vancomycin	Quantitative measurement of vancomycin
Basic Principle	Homogeneous enzyme immunoassay	Homogeneous enzyme immunoassay
Reportable Range	5.0 - 50 µg/mL	5.0 - 50 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 to Predicate	Not explicitly stated, but high correlation expected	Correlation Coefficient: 0.996 (vs. SYVA Emit 2000 Vancomycin Assay)Linear Regression: VITROS VANC assay = 1.00 X + 0.00 µg/mL (where X is the predicate device)
Precision	Performance comparable to predicate	Studies performed, details not provided in summary
Expected Values	Performance comparable to predicate	Studies performed, details not provided in summary
Linearity	Performance comparable to predicate	Studies performed, details not provided in summary
Specificity	Performance comparable to predicate	Studies performed, details not provided in summary

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

The provided summary mentions "patient samples" were used for correlation studies but does not specify the sample size for the test set used to compare the VITROS VANC assay against the predicate device.
The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective), but it's implied to be retrospective as patient samples were used for correlation against an existing, cleared assay.

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

This information is not applicable as the device is an in vitro diagnostic (IVD) assay for quantitative measurement. Ground truth for quantitative diagnostic assays typically refers to a reference method or a predicate device comparison rather than expert adjudication of images or clinical assessments.

4. Adjudication Method for the Test Set

This information is not applicable for this type of IVD assay. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., imaging studies) where human experts determine ground truth. For a quantitative assay, the comparison is against an established reference method or predicate device.

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

A MRMC comparative effectiveness study was not conducted and is not applicable for this device. This type of study involves human readers interpreting cases with and without AI assistance, which is irrelevant for a standalone quantitative IVD assay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The entire evaluation described is a standalone performance study, as it assesses the algorithm (the VITROS VANC assay) directly against a predicate device and other performance characteristics (precision, linearity, specificity) without human-in-the-loop interpretation. The performance metrics reported (correlation coefficient, linear regression) are direct measures of the assay's agreement with the predicate.

7. Type of Ground Truth Used

The ground truth for the comparison was established using a predicate device (SYVA Emit 2000 Vancomycin Assay) and patient samples. This means the new device's measurements were compared against the measurements obtained from an already FDA-cleared, commercially available assay using the same patient samples.

8. Sample Size for the Training Set

The document does not provide information regarding a specific "training set" sample size. For an IVD assay, the development process might involve numerous samples for calibration development and optimization, but these are typically not referred to as a distinct "training set" in the same way as machine learning models. The correlation and performance studies act as the validation.

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

Since a specific "training set" and its ground truth establishment mechanism are not detailed in the provided summary, this information is not available. However, for a chemical assay, the "ground truth" during development (analogous to training) would involve:

Using known concentration standards to develop calibration curves.
Testing against reference materials with established vancomycin concentrations.
Optimization of reagent formulations to achieve desired analytical performance.

Summary

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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: KOH 3386

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: December 8, 2004

1.3 Device Proprietary Name(s)

Trade Name(s):
VITROS Chemistry Products VANC Reagent VITROS Chemistry Products Calibrator Kit 11 VITROS Chemistry Products TDM Performance Verifier I, II, and III Common Name(s): Vancomycin assay and controls

1.4 Classification Name(s)

Vancomycin Test System: Class II (21 CFR 862.3950) Calibrators: Class II (21 CFR 862.3200) Assayed Controls: Class I (21 CFR 862. 3280)

1.5 Predicate device

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

The VITROS Chemistry Products TDM Performance Verifiers are substantially equivalent to the previously cleared VITROS Chemistry Products TDM Performance Verifiers.

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1.6 Device description

VITROS Chemistry Products Calibrator Kit 11 and TDM Performance Verifiers are packaged and sold separately.

1.7 Device intended use(s)

VITROS Chemistry Products VANC Reagent: For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5.1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

VITROS Chemistry Products Calibrator Kit 11: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).

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 VANC on VITROS Chemistry Systems.

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1.8 Comparison to predicate device: Reagent and Calibrators

The VITROS Chemistry Products VANC Reagent and VITROS Chemistry Products Calibrator Kit 11 are substantially equivalent to the SYVA Emit 2000 Vancomycin Assay and the SYVA Emit 2000 Vancomycin Calibrators, which were cleared by FDA (K020692 and K020845) for IVD use.

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

VITROS VANC assay = 1.00 X + 0.00 µg/mL, with a correlation coefficient of 0.996, 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 VANC assay, (refer to the VITROS Chemistry Products VANC Reagent Instructions for Use for summaries of the results of these studies).

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

DeviceCharacteristic	VITROS VANC Assay(New device)	SYVA Emit 2000 Vancomycin Assay(Predicate device)
Intended Use	Quantitative measurement ofvancomycin	Quantitative measurement ofvancomycin
Basic principle	Homogeneous enzymeimmunoassay	Homogeneous enzyme immunoassay
ReportableRange	5.0 - 50 µg/mL	5.0 - 50 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

1.9 Comparison to predicate device: Performance Verifiers

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 yancomycin so that the TDM Performance Verifiers may be used with the VITROS Chemistry Products VANC assay.

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1.10 Conclusions

and the state of the state of the state of the state of the state of the state of the states of the states of the states of the states of the states of the states of the stat

The data presented in the premarket notification provide a reasonable assurance that the VITROS Chemistry Products VANC reagent, VITROS Chemistry Products Calibrator Kits 11, 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.

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Image /page/4/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Carey A. Mayo, MS., RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. Regulatory Affairs MC00881 100 Indigo Creek Drive Rochester, NY 14626

Re: K043386

Trade/Device Name: VITROS Chemistry Products VANC Reagent VITROS Chemistry Products Calibrator Kit 11 VITROS Chemistry Products TDM Performance Verifiers I, II, and III

FEB - 7 2005

Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH, DLJ, DIF Dated: December 8, 2004 Received: December 9, 2004

Dear Ms. Mayo:

We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices 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 devices, 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 devices are 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 devices 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,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS. D.V.M. 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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2.0 Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

1. VITROS Chemistry Products VANC Reagent
  Koy3386
1. VITROS Chemistry Products Calibrator Kit 11
1. VITROS Chemistry Products TDM Performance Verifiers I, II, and III

For in vitro diagnostic use only. VITROS Chemistry Products VANC Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure vancomycin (VANC) concentration in human serum and plasma. Serum or plasma vancomycin measurements are used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.

1. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 11 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of vancomycin (VANC).
For in vitro diagnostic use only. VITROS TDM Performance 3. Verifier is an assaved control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VANC on VITROS Chemistry Systems.

Prescription Use (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

510(k) K043386

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

Page 5 of 46

Prescription Use
(Part 21 CFR 801 Subpart D)

Page 1 of 1

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.