VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.

VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Device Description

The VITROS Chemistry System uses Vitros Slides to perform discrete chemistry tests on body fluid specimens. All reactions necessary for a single quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.

The system is comprised of two main elements:

The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
The VITROS Chemistry System instrumentation, which provides automated use of the chemistry slides.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a modified in vitro diagnostic device, the VITROS Chemistry Products ALB Slides and VITROS Chemistry Products Calibrator Kit 4. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than outright performance acceptance criteria against a defined standard.

Therefore, the acceptance criteria and study details are primarily presented in terms of comparative equivalence to the predicate device, rather than explicit numerical thresholds.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in the typical sense (e.g., sensitivity > X%, specificity > Y%). Instead, the "acceptance criteria" appear to be demonstration of substantial equivalence to the predicate device, particularly through performance with "patient and quality control samples with measured albumin values spanning the assay range."

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (VITROS Chemistry Products ALB Slide (current) and VITROS Chemistry Products Calibrator Kit 4)	Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured albumin values spanning the assay range.
No significant change in clinical performance despite changes in sample volume (5.5 µL vs 10 µL) and quantity of reactive ingredients (bromcresol green dye: 125.4 µg vs 250 µg).	The information presented in the pre-market notification demonstrates that the performance of the VITROS ALB Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.

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

Sample Size: The document only generically states "patient and quality control samples." No specific number is provided for the test set.
Data Provenance: Not specified within the provided text (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. For in vitro diagnostic devices like this, "ground truth" for albumin measurement is typically established by reference methods or highly accurate laboratory analyzers, not human expert consensus like in image analysis.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. As an in vitro diagnostic device measuring a quantitative biomarker, adjudication by human readers is not relevant. The "ground truth" would be established by laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs without AI Assistance

This information is not applicable and therefore not provided. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or decision support tool involving human readers.

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

The device itself is a standalone measurement system (an automated chemistry analyzer utilizing specific slides and calibrators). The "algorithm" here refers to the chemical reaction and reflectance spectrophotometry, not a machine learning algorithm. The study effectively assesses the standalone performance of this system against the predicate system. The performance is assessed without human interpretation of raw data, beyond operating the instrument and reviewing results.

7. The Type of Ground Truth Used

For this type of in vitro diagnostic device, the ground truth would be established by:

Reference laboratory methods: Established, highly accurate methods for measuring albumin concentration.
Predicate device results: As the goal is substantial equivalence, the results from the predicate device often serve as a comparative ground truth for the new device.
Known concentrations in quality control samples: Quality control materials have certified albumin concentrations.

The document states "patient and quality control samples with measured albumin values." This implies that these samples had their albumin values determined by a reliable method (likely the predicate device or a reference method) to serve as the ground truth for comparison.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device. This is a chemical assay, not a machine learning model that requires a "training set" in the computational sense. The "training" of such a system involves the development and optimization of the chemical reagents and instrument parameters, which is a different process than data-driven machine learning training.

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

As explained above, the concept of a "training set" and associated "ground truth" in the machine learning sense does not directly apply to this in vitro diagnostic device. The development process would involve extensive experimentation and optimization against known chemical standards and clinical samples, but this is not typically referred to as establishing ground truth for a training set in regulatory submissions for chemical assays.

Summary

{0}------------------------------------------------

Summary Information

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: KOQ 3875

1. Submitter Ortho-Clinical Diagnostics, Inc. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 contact (585) 453-4041
  Contact Person: Marlene A. Hanna
Date Special 510(k) prepared: November 20, 2002 2. Preparation date
1. Device Trade or Proprietary Name: name VITROS Chemistry Products ALB Slides VITROS Chemistry Products Calibrator Kit 4 Common Name Classification Name: Albumin test system ( 21 CFR 862.1035).
1. Predicate The VITROS Chemistry Products ALB Slides (modified) and VITROS device Chemistry Products Calibrator Kit 4 are substantially equivalent to the VITROS Chemistry Products ALB Slides (current slide) and VITROS Chemistry Products Calibrator Kit 4.

Continued on next page

{1}------------------------------------------------

510(k) Summary, Continued

The VITROS Chemistry System uses Vitros Slides to perform discrete 5. Device chemistry tests on body fluid specimens. All reactions necessary for a single description quantitative measurement take place within the multi-layered analytical element of a Vitros Slide.

The system is comprised of two main elements:

1. The VITROS Chemistry Products range of chemistry products (in this case VITROS Chemistry Products ALB Slides, VITROS Chemistry Products Calibrator Kit 4, which are combined by the VITROS Chemistry System to perform the VITROS ALB test.
1. The VITROS Chemistry System instrumentation, which provides automated use of the chemistry slides. Multiple VITROS Chemistry Systems were cleared for market by separate 510(k) pre-market notifications (K890928, K890929, K922072, K946090 and K922072).

The VITROS Chemistry System and Calibrators are dedicated specifically for use only with the VITROS Chemistry Products range of products.

1. Device VITROS ALB Slides intended For in vitro diagnostic use only. use VITROS ALB Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
  VITROS Calibrator Kit 4 For in vitro diagnostic use only. VITROS Calibrator Kit 4 is intended for use in calibration of the VITROS Chemistry Systems for the quantitative measurement of ALB, BuBc, Fe, TBIL, TIBC, and TP.

Continued on next page

{2}------------------------------------------------

510(k) Summary, Continued

The VITROS Chemistry Products ALB Slide (modified) and VITROS 7. Comparison to predicate Chemistry Products Calibrator Kit 4 are substantially equivalent to VITROS Chemistry Products ALB Slide and VITROS Chemistry Products Calibrator device Kit 4 which were cleared by the FDA for in vitro diagnostic use. ALB Slide: (K812030, Cleared August 3, 1981) Calibrator Kit 4: (K922072, July 19, 1992).

Table 1 lists the characteristics of the tests performed using the VITROS ALB Slide (modified) and the VITROS ALB Slide (current).

Table 1 List of Slide Characteristics: Comparison to Predicate Device

DeviceCharacteristic	New DeviceVITROS ALB Slide	Predicate DeviceVITROS ALB Slide
	(Modified)	(Current)
Sample volume	5.5 µL	10 µL
Quantity ofReactiveIngredients perslide (test)	Bromcresol green dye: 125.4 µg	Bromcresol green dye: 250 µg
Concentrations ofSlide ReactiveIngredients percm-squared	No Change.	Bromcresol green: 139.4 µg /cm²
Intended Use	No change.	For in vitro diagnostic use only.VITROS ALB Slides quantitatively measurealbumin concentration in serum and plasma.
Basic principle	No Change.	Dry, multilayered slide utilizing reflectancespectrophotometry
Sample type	No Change.	Serum , plasma
Reportable RangeSerum, Plasma	No Change.	1.0 - 6.00 g/ dL (Conv. Units)10.0 - 60.0 g/L (SI Units)152 - 912 µmol/L (Alternate Units)
Instrumentation	No Change.	VITROS 250, 500, 750 and 950 Series Analyzers
Incubation timeand temperature	No Change.	Approximately ,5 minutes at 37°C

Continued on next page

{3}------------------------------------------------

510(k) Summary, Continued

The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS ALB Slides (modified) for use with human serum and plasma is substantially equivalent to the cleared predicate device.

Equivalence was demonstrated using manufactured slides along with patient and quality control samples with measured albumin values spanning the assay range.

The information presented in the premarket notification provides a reasonable assurance that the VITROS ALB Slides (modified) for use with human serum and plasma is safe and effective for the stated intended use.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the caduceus symbol.

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

DEC 1 0 2002

Ms. Marlene A. Hanna Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

Re: . K023875

Trade/Device Name: VITROS Chemistry Products ALB Slides/ VITROS Chemistry Products Calibrator Kit 4

Regulation Number: 21 CFR § 862.1035 Regulation Name: Albumin test system Regulatory Class: II Product Code: CIX: JIX Dated: November 20, 2002 Received: November 21, 2002

Dear Ms. Hanna:

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.

{5}------------------------------------------------

Page 2

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). 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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Statement of Intended Use

Page 1 of 1

510(k) Number (if known):

Summary and Explanation of

Test:

Device Name:

Intended Use:

K023875

VITROS Chemistry Products ALB Slides VITROS Chemistry Products Calibrator Kit 4

VITROS Chemistry Products ALB Slides For in vitro diagnostic use only. VITROS ALB Slides quantitatively measure albumin (AL concentration in serum and plasma.

Of all serum proteins, albumin is present in the highest concentration. It maintains the plasma oncotic pressure and the transport of many substances. Increased serum albumin may indicate dehydration or hyperinfusion with albumin; a decrease is found in rapid hydration, overhydration, severe malnutrition and malabsorbtion, severe diffuse liver necrosis, chronic active hepatitis, and neoplasia. Albumin is commonly reduced in chronic alcoholism, pregnancy, renal protein loss, thyroid dysfunction, peptic ulcer disease, and chronic inflammatory disease. '

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C Benson for B Jean Cooper
(Division Sign-Off)
Division: Common Laboratory Devices

510(k) Number:	K023875
----------------	---------

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
------------------------------------------	----	----------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1035 Albumin test system.

(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.