For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.

For in vitro diagnostic use only. VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.

Device Description

VITROS Chemistry Products Calibrator Kit 23 is a liquid ready use kit containing five levels for the calibration of VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.

These calibrators are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

VITROS Chemistry Products PALB Performance Verifiers contain two levels of liquid ready to use assayed controls for use in monitoring performance of PALB Reagents on VITROS 5,1 FS Chemistry Systems.

These controls are prepared from processed human serum to which inorganic salt, buffers and preservative have been added.

AI/ML Overview

This is a 510(k) premarket notification for in vitro diagnostic devices, specifically calibrators and controls for chemical analyzers. These types of devices do not typically involve AI components, MRMC studies, or specific performance metrics like sensitivity and specificity measured against a true disease state. Instead, performance is evaluated through analytical studies demonstrating their ability to accurately calibrate and monitor the performance of an assay.

Therefore, many of the requested fields are not applicable to this submission.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the traditional sense for an AI/CADe device (e.g., minimum sensitivity/specificity). Instead, the device's performance is demonstrated through its substantial equivalence to a predicate device and its intended use as a calibrator and control. The primary performance characteristic for these devices is their ability to perform their intended function (calibrate and monitor an assay effectively).

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
VITROS Chemistry Products Calibrator Kit 23
Intended Use	Calibrate VITROS 5,1 FS Chemistry Systems for quantitative prealbumin measurement.	Substantially equivalent to predicate, designed for this use.
Fluid Matrix	Processed human serum with inorganic salts, buffers, and preservatives.	Device composition matches this description.
Analyte Levels	Five levels	Device has five levels.
Analyte	Prealbumin (transthyretin)	Device contains prealbumin.
Traceability	CRM470	Device is traceable to CRM470.
Format	Liquid ready to use	Device is liquid ready to use.
VITROS Chemistry Products PALB Performance Verifiers I and II
Intended Use	Monitor performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.	Substantially equivalent to predicate, designed for this use.
Fluid Matrix	Processed human serum with inorganic salt, buffers, and preservative.	Device composition matches this description.
Analyte Levels	Low and High	Device has low and high levels.
Analyte	Prealbumin (transthyretin)	Device contains prealbumin.
Format	Liquid ready to use	Device is liquid ready to use.

Study Proving Acceptance Criteria:

The document focuses on demonstrating substantial equivalence to existing predicate devices (VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, cleared by FDA K041799). This is the key "study" or justification for clearance in this context. The comparison explicitly highlights similarities in intended use (though for different analytes), fluid matrix, format, and traceability.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable to this type of device. The "test set" in this context would be the internal analytical validation studies performed by the manufacturer to ensure the calibrators and controls function as intended and are stable. These studies typically involve a series of measurements over time and across different instruments. The document does not provide details of such internal studies, which are usually part of the detailed submission reviewed by the FDA but not summarized in the 510(k) summary itself. The provenance of the human serum used is not specified in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. "Ground truth" in this context would relate to the certified values of the calibrator and control materials. This is established through rigorous analytical measurement and traceability to a recognized standard (CRM470), not through expert consensus in a clinical diagnostic sense. Expert medical professionals are not used to establish the "ground truth" for calibrator values.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication is relevant for diagnostic interpretations, not for the analytical performance of calibrators and controls.

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

Not applicable. This device is not an AI/CADe system intended for human reader assistance.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for these devices is the assigned analyte value (prealbumin level) in each calibrator and control, which is established through:

Traceability to a recognized reference material: The document states "Traceability: CRM470". CRM470 likely refers to a Certified Reference Material, which provides a highly accurate and precise measurement of the analyte.
Methodology: Internal validation studies by the manufacturer using established analytical methods.

8. The sample size for the training set

Not applicable. This device does not use machine learning and therefore does not have a "training set."

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

Not applicable (no training set).

Summary

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DEC - 9 2004

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically 'K042838'. The characters are written in a bold, sans-serif font, and they appear to be handwritten. The numbers are easily readable, and the 'K' is distinct.

3.0 510(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.

and the comments of the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the con

The assigned 510(k) number is:

Submitter name, address, contact 3.1

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4253 Fax: (585) 453-3368

Contact Person: Darlene J. Phillips

3.2 Date of Preparation:

October 13, 2004

3.3 Device Proprietary Names:

Trade Names	VITROS Chemistry Products Calibrator Kit 23VITROS Chemistry Products PALB Performance Verifier I and II
Common Name	Prealbumin calibrator and controls

の 2007年の1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には、1000年には1000年に1000

3.4 Classification Names

Classification Name: Calibrator (862.1150): Class II The Clinical Chemistry and Toxicology Panel of the FDA has placed calibrators in Class II.

Classification Name: Quality Control material (assayed and unassayed) (862.1660): Class I: The Clinical Chemistry and Toxicology Panel of the FDA has placed Quality Control material (assayed and unassayed) for clinical chemistry in Class I. Since this device is an assayed control, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

3.5 Predicate devices

The VITROS Chemistry Products Calibrator Kit 23 and VITROS Chemistry Products PALB Performance Verifiers are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 17 and VITROS Chemistry Products hsCRP Performance Verifiers, respectively. The predicate devices were cleared by FDA (K041799) for IVD use.

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3.6 Device description

VITROS Chemistry Products Calibrator Kit 23

VITROS Chemistry Products Calibrator Kit 23 is a liquid ready use kit containing five levels for the calibration of VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.

These calibrators are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

VITROS Chemistry Products PALB Performance Verifiers I and II

VITROS Chemistry Products PALB Performance Verifiers contain two levels of liquid ready to use assayed controls for use in monitoring performance of PALB Reagents on VITROS 5,1 FS Chemistry Systems.

These controls are prepared from processed human serum to which inorganic salt, buffers and preservative have been added.

3.7 Device intended use

VITROS Chemistry Products Calibrator Kit 23

For in vitro diagnostic use only

VITROS Chemistry Products Calibrator Kit 23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of prealbumin.

VITROS Chemistry Products PALB Performance Verifiers I and II

For in vitro diagnostic use only

VITROS Chemistry Products PALB Performance Verifiers are assayed controls used to monitor the performance of PALB Reagent on VITROS 5,1 FS Chemistry Systems.

3.8 Comparison to predicate device

Tables 1 and 2 provide similarities and differences between the new devices and predicate devices.

Continued on next page

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Table 1 lists the similarities and differences of the device characteristics between new device, Table 1 VITROS Chemistry Products Calibrator Kit 23 and predicate device, VITROS Chemistry Products Calibrator Kit 17.

DeviceCharacteristic	VITROS Calibrator Kit 23New device	VITROS Calibrator Kit 17Predicate device
Intended Use	For in vitro diagnostic use only.VITROS Chemistry ProductsCalibrator Kit 23 is used to calibrateVITROS 5,1 FS Chemistry Systemsfor the quantitative measurement ofprealbumin (PALB).	For in vitro diagnostic use only.VITROS Chemistry Products CalibratorKit 17 is used in conjunction withVITROS Chemistry Products FSCalibrator 1 to calibrate VITROS 5,1 FSChemistry Systems for the quantitativemeasurement of C-reactive protein (CRPusing VITROS hsCRP Reagent.
Fluid Matrix	A base matrix of processed humanserum to which inorganic salts,buffers, and preservatives have beenadded.	A base matrix of stabilized human serumto which analytes and preservatives havebeen added
Analyte Levels	Five levels	Single level
Analyte	Prealbumin (transthyretin)	C-reactive protein
Traceability	CRM470	Same
Format	Liquid ready to use	Same

Table 2 Table 2 lists the similarities and differences of the device characteristics between new device, VITROS PALB Performance Verifiers and predicate device, VITROS hsCRP Performance Verifiers

DeviceCharacteristic	VITROS PALB PerformanceVerifiersNew device#2	VITROS hsCRP PerformanceVerifiersPredicate device#2
Intended Use	For in vitro diagnostic use only.VITROS Chemistry Products PALBPerformance Verifiers are assayedcontrols used to monitor theperformance of PALB Reagent onVITROS 5,1 FS Chemistry Systems.	For in vitro diagnostic use only. VITROSChemistry Products hsCRP PerformanceVerifiers are assayed controls used tomonitor performance of hsCRP Reagenton VITROS 5,1 FS Chemistry Systems.
Fluid Matrix	A base matrix of processed humanserum to which inorganic salt,buffers and preservative have beenadded.	A base matrix of human plasma andplasma proteins to which stabilizers andpreservative have been added.
Analyte Levels	Low and High	Low, Medium and High
Analyte	Prealbumin (transthyretin)	C-reactive protein
Format	Liquid ready to use	Same

Continued on next page

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" surrounding the top half of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 9 2004

Ms. Darlene J. Phillips, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, NY 14626

K042838 Re:

Trade/Device Name: VITROS Chemistry Products Calibrator Kit 23 · VITROS Chemistry Products PALB Performance Verifiers I and II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: October 13, 2004 Received: October 14, 2004

Dear Ms. Phillips:

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 (OS) 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 (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,

Cornelia B. Lorks

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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1.0 Indications for Use

510(k) Number(if known):	K042838
Device Name:	VITROS Chemistry Products Calibrator Kit 23VITROS Chemistry Products PALB Performance Verifiers I and II
Indications for Use:	For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit23 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitativemeasurement of prealbumin.For in vitro diagnostic use only. VITROS Chemistry Products PALBPerformance Verifiers are assayed controls used to monitor the performanceof PALB Reagent on VITROS 5,1 FS Chemistry Systems.
Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042838

Page 1 of 1

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.