For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.

For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.

Device Description

VITROS Chemistry Products Calibrator Kit 99 is a five level set of fluids used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of 0,1-antitrypsin (AAT), and haptoglobin (HPT) using VITROS Chemistry Products AAT and HPT Reagents. VITROS Chemistry Products Calibrator Kit 99 is prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III is a three level set of assayed liquid controls used to monitor the performance of cx1-antitrypsin (AAT), and haptoglobin (HPT) measurements, using VITROS Chemistry Products AAT and HPT Reagents, respectively, with the VITROS 5,1 FS Chemistry Systems. The VITROS AAT/HPT Performance Verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

Important Note: The provided text is a 510(k) summary for a calibrator kit and performance verifiers (quality control materials) used in laboratory chemistry systems. These types of devices do not typically involve the same kind of performance studies (e.g., studies with human readers, AI algorithms, or pathology ground truth) as imaging or diagnostic AI/ML devices. The "acceptance criteria" here refer to the device's ability to perform its intended function (calibrating measurements and monitoring performance) in a manner substantially equivalent to a predicate device, rather than diagnostic accuracy against a clinical gold standard.

Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of submission as the study focuses on analytical performance and equivalence to a predicate, not clinical diagnostic utility in the same way as an AI-powered diagnostic tool.

Acceptance Criteria and Study Details

The submission focuses on demonstrating substantial equivalence of the new Calibrator Kit and Performance Verifiers to previously cleared predicate devices. The "acceptance criteria" are implied by showing that the new devices perform their intended functions (calibrating and monitoring AAT and HPT measurements) effectively and are similar to the predicate devices in formulation and function, with the key difference being the expanded analyte-specific intended use for Haptoglobin (HPT).

1. A table of acceptance criteria and the reported device performance:

Since this is a chemistry calibrator/control device, specific "acceptance criteria" for diagnostic accuracy (sensitivity, specificity, AUC, etc.) are not directly applicable in the same way they would be for an AI diagnostic device. Instead, the "performance" demonstrated is that the new devices function adequately for their intended purpose of calibrating and monitoring measurements on the VITROS 5,1 FS Chemistry Systems.

The acceptance is based on demonstrating the new devices are substantially equivalent to predicate devices. The "performance" is implicitly demonstrated through internal validation studies (not detailed in this summary) that support the expanded intended use and show the materials are suitable for calibrating and monitoring AAT and HPT.

Characteristic	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance
Intended Use	New device is suitable for calibrating and monitoring both AAT and HPT.	"VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids." and "VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems." (Expanded to include HPT, which is the key change from the predicate).
Analytes Covered	Must effectively support measurement of AAT and HPT.	Supports α₁-Antitrypsin (AAT) and Haptoglobin (HPT) analytes.
Traceability	Maintain traceable reference material.	Uses the same traceability: BAM-IRMM-LGC ERM-DA470 Reference Material.
Number of Levels	Consistent with calibrator/control requirements.	Calibrator Kit: Five levels. Performance Verifiers: Three levels. (Consistent with predicate).
Format	Liquid ready to use.	Liquid ready to use. (Consistent with predicate).
Fluid Matrix	From processed human serum.	Processed human serum with inorganic salts, buffers, and preservatives. (Consistent with predicate).
Overall Safety and Effectiveness	Device is safe and effective for its stated intended uses.	"The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 99 and the VITROS Chemistry Products AAT/HPT Performance Verifiers I, II and III are safe and effective for the stated intended uses."

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 / Not Provided in Summary: This summary does not contain details about specific "test sets" or clinical data in the way an AI/ML diagnostic would. The evaluation is based on analytical performance and substantial equivalence. For calibrators and controls, this typically involves internal laboratory testing to assign values and ensure stability, linearity, and precision, using methods established by the manufacturer and often following international standards. The specific data (e.g., number of runs, replicates, lots, etc.) that support the performance of the calibrators and verifiers is not detailed in this summary but would have been part of the full 510(k) submission.

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 the context of this device refers to the assigned values of the calibrator and control materials, which are established through a rigorous metrological process, often traceable to international reference materials or methods (as indicated by "BAM-IRMM-LGC ERM-DA470 Reference Material"). This is a technical process, not an expert consensus involving clinical specialists.

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

Not Applicable: Adjudication methods are relevant for clinical interpretations, especially in imaging or complex diagnostic scenarios where human interpretation can vary. This is not applicable to an in vitro calibrator or control material.

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 is a calibrator/control device, not an AI or imaging diagnostic device that involves human reader interpretation.

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

Not Applicable: This device is a consumable component (calibrator/control) used in an in vitro diagnostic system (VITROS 5,1 FS Chemistry Systems). It is not a standalone algorithm.

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

Analytical Traceability to Reference Materials: The "ground truth" for the calibrator and control values is established through analytical methods with traceability to internationally recognized reference materials (BAM-IRMM-LGC ERM-DA470 Reference Material). This ensures accuracy and consistency of the assigned values.

8. The sample size for the training set:

Not Applicable / Not Provided in Summary: This summary does not provide details about a "training set" as it is typically understood for AI/ML algorithms. The development of calibrators and controls involves extensive analytical testing (e.g., stability studies, value assignment studies, matrix equivalency studies, precision studies) but not "training data" in the AI sense.

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

Not Applicable / Not Provided in Summary: As above, no "training set" in the AI sense. The ground truth for the analytical parameters (e.g., calibrator values) is established through reference methods and materials.

Summary

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

5.0 510(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: 1000000

Submitter name, address, contact 5.1

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester. New York 14626-5101 Telephone: (585) 453- 4041 Facsimile: (585) 453-3368 Contact Person: Marlene Hanna

Date of Preparation: April 5, 2006 5.2

Device Proprietary Names: 5.3

VITROS Chemistry Products Calibrator Kit 99 Trade Names:

VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III

Common Name: Calibrators and controls

5.4 Classification Names

Classification Name: Calibrator (21 CFR 862.1150): Class II

Classification Name: Quality Control material (assayed and unassayed) (21 CFR 862.1660): Class I: Reserved

Predicate devices 5.5

The VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.

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

5.6 Device description

VITROS Chemistry Products Calibrator Kit 99

VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III

5.7 Device intended use

VITROS Chemistry Products Calibrator Kit 99

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of proteins in body fluids.

VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III For in vitro diagnostic use only. VITROS Chemistry Products AAT/HPT Performance Verifiers are assayed controls used to monitor the performance of protein measurements in body fluids on VITROS 5,1 FS Chemistry Systems.

Continued on next page

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

Comparison to predicate device 5.8

The VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II and III, respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.

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

Table 1 lists the similarities and differences of the device characteristics between new device VITROS Chemistry Products Calibrator Kit 99 (new intended use) and predicate device, VITROS Chemistry Products Calibrator Kit 99 (current Product).

TABLE 1

Device	VITROS Calibrator Kit 99	VITROS Calibrator Kit 99
Characteristic	(New intended use)New Device#1	(Current Product)Predicate Device#1
Intended UseStatement	For in vitro diagnostic use only.VITROS Chemistry ProductsCalibrator Kit 99 is used tocalibrate VITROS 5,1 FSChemistry Systems for thequantitative measurement ofproteins in body fluids.	For in vitro diagnostic use only.VITROS Chemistry ProductsCalibrator Kit 99 is used tocalibrate VITROS 5,1 FSChemistry Systems for thequantitative measurement of α1-antitrypsin (AAT).
Analytes	α₁-Antitrypsin(AAT),Haptoglobin (HPT)	α₁-Antitrypsin (AAT)
Traceability	BAM-IRMM-LGC(Bundesanstalt fürMaterialforschung und -prüfung /Institute for Reference Methodsand Materials / Laboratory of theGovernment Chemist) ERM-DA470 Reference Material¹	BAM-IRMM-LGC(Bundesanstalt fürMaterialforschung und -prüfung /Institute for Reference Methodsand Materials / Laboratory of theGovernment Chemist) ERM-DA470 Reference Material¹
Number of levels	Five	Five
Format	Liquid ready to use	Liquid ready to use
Fluid Matrix	Processed human serum	Processed human serum

Continued on next page

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

Table 2 lists the similarities and differences of the device characteristics between new device VITROS AAT/HPT Performance Verifiers and predicate device, VITROS AAT Performance Verifiers.

DeviceCharacteristic	VITROS AAT/HPT PerformanceVerifiers I, II and IIINew device #2	VITROS AAT PerformanceVerifiers I, II, and IIIPredicate device #2
Intended UseStatement	For in vitro diagnostic use only.VITROS Chemistry ProductsAAT/HPT Performance Verifiersare assayed controls used tomonitor performance of proteinmeasurements in body fluids withVITROS 5,1 FS ChemistrySystems.	For in vitro diagnostic use only.VITROS Chemistry ProductsAAT Performance Verifiers areassayed controls used tomonitor performance ofVITROS AAT Reagents onVITROS 5,1 FS ChemistrySystems.
Analytes	α₁-Antitrypsin(AAT), Haptoglobin(HPT)	α₁-Antitrypsin (AAT)
Number oflevels	Three	Three
Format	Liquid ready to use	Liquid ready to use
Fluid Matrix	Prepared from processed humanserum to which inorganic salts,buffers, and preservatives havebeen added.	Prepared from processed humanserum to which inorganic salts,buffers, and preservatives havebeen added.

ર . 9 Conclusions

The information presented in this premarket notification provide a reasonable assurance that the VITROS Chemistry Products Calibrator Kit 99 and the VITROS Chemistry Products AAT/HPT Performance Verifiers I, II and III are safe and effective for the stated intended uses.

Ortho-Clinical Diagnostics, Inc. believes that the VITROS Chemistry Products Calibrator Kit 99 (new intended use), and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III are substantially equivalent to the VITROS Chemistry Products Calibrator Kit 99 (current product), and VITROS Chemistry Products AAT Performance Verifiers I, II, and III respectively. The predicate devices were both previously cleared by the FDA (K052819) for IVD use.

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

Image /page/4/Picture/1 description: The image shows a black and white logo. The logo is a circular seal with text around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 4 2006

Ortho-Clinical Diagnostics, Inc. c/o Ms. Marlenc Hanna Regulatory Affairs Manager 100 Indigo Creek Dr. Rochester, NY 14626-5101

Rc: K060940

Trade/Device Name: VITROS Chemistry Products Calibrator Kit 99 VITROS Chemistry Products AAT/HPT Performance Verifier I, II and III Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX, JJX Dated: April 5, 2006 Received: April 6, 2006

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) requlation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FI>A 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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,

Zohut H. Becker/

Robert I .. Becker, Jr., M.D/, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

4.0 Indications for Use Statement

_ . . . . . . ________________________________________________________________________________________________________________________________________________________________

510(k) Number(if known):	K060940
Device Name:	VITROS Chemistry Products Calibrator Kit 99VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III
Indications for Use:	For in vitro diagnostic use only.VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS5,1 FS Chemistry Systems for the quantitative measurement of proteinsin body fluids.For in vitro diagnostic use only.VITROS Chemistry Products AAT/HPT Performance Verifiers are assayedcontrols used to monitor the performance of protein measurements inbody fluids on VITROS 5,1 FS Chemistry Systems.

510(k) Number(if known):

K060940

Device Name:

VITROS Chemistry Products Calibrator Kit 99VITROS Chemistry Products AAT/HPT Performance Verifier I, II, and III

Indications for Use:

For in vitro diagnostic use only.VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS5,1 FS Chemistry Systems for the quantitative measurement of proteinsin body fluids.For in vitro diagnostic use only.VITROS Chemistry Products AAT/HPT Performance Verifiers are assayedcontrols used to monitor the performance of protein measurements inbody fluids on VITROS 5,1 FS Chemistry Systems.

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

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

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

ina Den
Division Sim-Off

Lavision Sign-Off

__. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

।

Office of In Vitro Diagnostic Device Evaluction and Safety

Ks 60745

。・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

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.