Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Device Description

The VITROS urCR assay is performed using the VITROS Chemistry Products urCR DT Slides, and the VITROS Chemistry Products DT Calibrator Kit on VITROS DT60/DT60II Chemistry Systems.

The VITROS urCR Slide is a multilayered, analytical element coated on a polyester support.

A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a leuco dye to produce a colored product.

Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is oxidized. The resulting rate of change in reflection density is proportional to the concentration of creatinine in the sample

Once a calibration has been performed for each slide lot, creatinine concentration in unknown samples can be determined using the software-resident rate math model and the change in reflectance calculated for each unknown test slide.

VITROS DT Calibrator Kit contains four levels of lyophilized standards with corresponding diluents. The standards are prepared from processed bovine serum to which organic analytes, electrolytes, stabilizers, and preservatives have been added. The diluents are prepared from processed water to which inorganic salts have been added. Once reconstituted, the appropriate standards are used to calibrate VITROS DT60/DT60 II Chemistry Systems for the quantitative measurement of creatinine in urine.

Calibration of the VITROS urCR assay requires the use of bottles 1, 2 and 4 of the VITROS DT Calibrator Kit.

AI/ML Overview

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study:

Device: VITROS Chemistry Products urCR DT Slides (modified device) and VITROS Chemistry Products DT Calibrator Kit.
Intended Use (urCR DT Slides): Quantitatively measure creatinine concentration in urine for diagnosis and treatment of renal diseases, monitoring renal dialysis, and as a calculation basis for other urine analytes.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the modified device's performance characteristics and compares them to a predicate device. While explicit "acceptance criteria" for quantitative metrics aren't stated as pass/fail thresholds, the comparison table implies what was considered acceptable for substantial equivalence. The key performance aspects are the analytical range and calibration traceability.

Acceptance Criteria / Characteristic	Modified Device (VITROS urCR assay) Reported Performance	Predicate Device (VITROS urCR assay original) Reported Performance
Intended Use	No change (Matches predicate)	For in vitro diagnostic use only. Quantitatively measure creatinine concentration in urine.
Calibration Traceability	Traceable to Gas Chromatography Isotope Dilution Mass Spectrometry (GC/IDMS) method¹ and NIST SRM®914, creatinine standard reference material.	Traceable to Certified NIST Reference Material SRM® 914a.
Reference Interval (Urine)	Males: 1000 – 2000 mg/day² Females: 800 – 1800 mg/day²	800 – 2800 mg/day
Reportable Range (Urine)	1.0 – 339.2 mg/dL* (*After multiplying by a dilution factor of 21)	2.1 – 346.5 mg/dL* (*After multiplying by a dilution factor of 21)
Sample Type	No change (Matches predicate)	Urine
Basic Principle	No change (Matches predicate)	Colorimetric rate
Instrumentation	No change (Matches predicate)	VITROS DTSC/DTSCII Module (presumably VITROS DT60/DT60II Chemistry Systems as stated in device description)

Conclusion on Acceptance: The document primarily focuses on demonstrating substantial equivalence to the predicate device. The "acceptance criteria" are therefore inferred to be that the modified device's characteristics (intended use, calibration, reportable range, etc.) are equivalent to, or demonstrate comparable performance to, the predicate device. The changes noted (e.g., specific traceability methods, slightly refined reference intervals, and a minor adjustment in the lower boundary of the reportable range) were deemed acceptable as they did not impact the substantial equivalence based on the rationale provided.

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

The document states: "Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples, and human urine with measured creatinine values spanning the assay range."

Sample Size for Test Set: Not explicitly stated. The specific number of "human urine" samples is not provided, nor are the quantities of quality control fluids or proficiency samples.
Data Provenance: The data comes from tests on "human urine," "quality control fluids," and "proficiency samples." The geographic origin (country) is not specified. The study is implied to be prospective in nature, as it's demonstrating the performance of a newly "modified device" and its manufactured reagents.

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

This is a chemical assay, not an imaging device requiring expert interpretation. The "ground truth" for creatinine concentration would be established by reference methods or validated laboratory measurements.

Number of Experts: Not applicable in the traditional sense of human readers/interpreters.
Qualifications of Experts: Not applicable. Ground truth for chemical analytes is established by highly accurate and precise analytical methods. The document mentions traceability to:
- Gas Chromatography Isotope Dilution Mass Spectrometry (GC/IDMS) method
- NIST SRM®914, creatinine standard reference material (National Institute of Standards and Technology Standard Reference Material). These describe the methodology and reference standards for establishing ground truth, not human experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is a chemical assay, not involving human interpretation that would require adjudication. The performance is assessed by comparing results from the device to established reference methods/ground truth, and potentially by comparing the modified device's performance to the predicate device's performance.

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

MRMC Comparative Effectiveness Study: No. This is a chemical assay device, not an AI-assisted diagnostic imaging or interpretation system involving human readers.

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

Standalone Performance: Yes, implicitly. The device itself (VITROS urCR assay) operates as an automated system measuring creatinine. The performance evaluation described (using various samples and demonstrating equivalence) represents the "standalone" performance of the assay system without human intervention in the measurement process itself, beyond sample loading and calibration. The result is quantitative and objective, not subject to human interpretation in the way, for example, a radiological image would be.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for creatinine concentration was established through reference methods and certified reference materials. Specifically:
- Gas Chromatography Isotope Dilution Mass Spectrometry (GC/IDMS) method.
- NIST SRM®914 (National Institute of Standards and Technology Standard Reference Material) for creatinine.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This document describes a modification to an existing chemical assay, which typically involves analytical validation rather than machine learning "training sets." While there would have been extensive development and optimization work, the concept of a "training set" in the context of an AI/ML algorithm is not relevant here. The device's calibration process involves known standards, but this is a calibration, not an algorithmic training process as understood in AI/ML.

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

How Ground Truth for Training Set was Established: Not applicable. As noted above, typical machine learning training sets are not relevant to this type of chemical assay device. The ground truth for the calibrators is established by traceability to GC/IDMS and NIST SRM®914, as described in point 7.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Ortho-Clinical Diagnostics. The logo consists of a symbol on the left, followed by the text "Ortho-Clinical Diagnostics" in a bold, sans-serif font. Below the text, there is a line, and below the line, there is the text "a Johnson & Johnson company" in a smaller font.

100 Indigo Creek Drive Rochester, New York 14626-5101

MAY 2 5 2007

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: K071215

Ortho-Clinical Diagnostics, Inc. 1. Submitter 100 Indigo Creek Drive MC00881 name, address, con-Rochester, New York 14626-5101 tact Phone: (585) 453-3143 FAX: (585) 453-3368 Email: mbyrne3@ocdus.jnj.com Michael M. Byrne Contact Person:
May 1. 2007 2. Preparation
date
Trade or Proprietary Name: 3. Device VITROS Chemistry Products urCR DT Slides name VITROS Chemistry Products DT Calibrator Kit

VITROS urCR assay Common Name: Classification Name: Creatinine test system (21 CFR 862.1225).

VITROS DT Calibrator Kit Common Name: Classification Name: Calibrator (21 CFR 862.1150)

The VITROS urCR assay (modified device) is substantially equivalent to the Predicate 4. VITROS urCR assay (original device). The FDA cleared the VITROS Chemdevice istry Products urCR DT Slides and VITROS Chemistry Products DT Calibrator Kit on March 21, 1994 (K934071) under the following product names:
KODAK EKTACHEM DT SLIDES (urCR) and

KODAK EKTACHEM DT Calibrator Kit

Note: With the purchase of KODAK Clinical Products Division by Johnson and Johnson, the product branding was revised to VITROS Chemistry Products urCR DT Slides and VITROS Chemistry Products DT Calibrator Kit.

Continued on next page

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510(k) Summary, Continued

The VITROS urCR assay is performed using the VITROS Chemistry Products 5. Device deurCR DT Slides, and the VITROS Chemistry Products DT Calibrator Kit on scription VITROS DT60/DT60II Chemistry Systems.

The VITROS urCR Slide is a multilayered, analytical element coated on a polyester support.

Once a calibration has been performed for each slide lot, creatinine concentration in unknown samples can be determined using the softwareresident rate math model and the change in reflectance calculated for each unknown test slide.

Calibration of the VITROS urCR assay requires the use of bottles 1, 2 and 4 of the VITROS DT Calibrator Kit.

Device intended use

For in vitro diagnostic use only.

VITROS Chemistry Products urCR DT Slides quantitatively measure creatinine concentration in urine.

For in vitro diagnostic use only.

VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Continued on next page

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510(k) Summary, Continued

The VITROS urCR assay (modified device) is substantially equivalent 7. Comparison to the predicate, VITROS urCR assay (original), which was cleared by the to predicate FDA (K934071) for in vitro diagnostic use. device

DeviceCharacteristic	Modified DeviceVITROS urCR assay(modified)	Predicate DeviceVITROS urCR assay (original)
Intended Use	No change	For in vitro diagnostic use only.VITROS urCR DT Slides quantitativelymeasure creatinine concentration inurine.
Calibration trace-ability	The values assigned to theVITROS Chemistry Products DTCalibrator Kit for Creatinine aretraceable to a Gas ChromatographyIsotope Dilution Mass Spectrome-try (GC/IDMS) method¹ and NISTSRM®914, creatinine standard ref-erence material.	For in vitro diagnostic use only.VITROS Chemistry Products DT Cali-brator Kit is specially formulated foruse as calibrators for ALB, ALKP,ALT, AMYL, AST, TBIL, NBIL,BUN/UREA, Ca, CHOL, CK, Cl., CO₂,CREA, CRSC, Fe, GGT, GLU, HDLC,K+, LAC, LDH, LIPA, Mg, Na+, NH₃,PHOS, TP, TRIG, urCR, and URIC onVITROS DT Chemistry Systems.Traceable to Certified NIST (NationalInstitute of Standards and Technology)Reference Material SRM® (StandardReference Material) 914a.
Reference Interval(Urine)	Males: 1000 – 2000 mg/day²Females: 800 – 1800 mg/day²	800 – 2800 mg/day
Reportable rangeUrine	1.0 – 339.2 mg/dL**After multiplying by a dilution factor of 21	2.1 – 346.5 mg/dL**After multiplying by a dilution factor of 21
Sample type	No change	Urine
Basic principle	No change	Colorimetric rate
Instrumentation	No change	VITROS DTSC/DTSCII Module

Table 1 List of Assay Characteristics: Comparison to Predicate Device

Continued on next page

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510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that the 8. Conclusions The miormation probestical assay (modified device) for use with human urine is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured reagents along with quality control fluids, proficiency samples, and human urine with measured creatinine values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS urCR assay (modified device) for use with human urine is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus, which is a symbol often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 5 2007

Ortho-Clinical Diagnostics, Inc. c/o Michael M. Byrne, RAC Regulatory Affairs Associate 100 Indigo Creek Drive Rochester, NY 14626-5101

K071215 Re:

Trade/Device Name: VITROS Chemistry Products urCR DT Slides, VITROS Chemistry Products DT Calibrator Kit Regulation Number: 21 CFR §862.1215 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: JFY, JIX Dated: May 1, 2007 Received: May 2, 2007

Dear Mr. Byrne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978) in accordance with the provisions of the Federal Food, Drug, de ricos mat have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (1107 that de not requently subject to the general controls provisions of the Act. The I ou may, dierelere, mains 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 n may or subject to back and 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) This letter will anow you to begin mailing of substantial equivalence of your device to a legally promation notification - Firesults 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, II you desire specific information association of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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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Indications for Use

510(k) Number (if known):	K071215
Device Name:	VITROS Chemistry Products urCR DT Slides
Indications for Use:	For in vitro diagnostic use only.VITROS urCR DT Slides quantitatively measure creatinineconcentration in urine on the DT60/DT60 II analyzer.Creatinine measurements are used in the diagnosis and treatmentof renal diseases, in monitoring renal dialysis, and as acalculation basis for measuring other urine analytes.
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

071215

Page 1 of 2

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

VITROS Chemistry Products DT Calibrator Kit

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

KD71215

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. Benam
Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K09/215

Page 2 of 2

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.