For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Device Description

Not Found

AI/ML Overview

The provided document describes a 510(k) summary for a modified medical device, the "VITROS Chemistry Products TRIG Slides," and references a study conducted to demonstrate substantial equivalence to a predicate device. This is a Special 510(k) submission, indicating that the modifications did not alter the fundamental scientific technology or intended use, but rather involved changes to the product that necessitated new verification and validation. Therefore, the study described focuses on demonstrating that the modified device continues to meet established performance criteria.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that various performance characteristics were considered for potential hazards and that validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing.

The characteristics considered, implying where acceptance criteria would have been applied, are:

Performance Characteristic	Reported Device Performance
Accuracy	Met pre-determined acceptance criteria. (Implies performance within acceptable limits for comparison to a reference method or the predicate device.)
Precision	Met pre-determined acceptance criteria. (Implies acceptable variability in results.)
Linearity	Met pre-determined acceptance criteria. (Implies accurate measurement across the specified assay range.)
Potential Interferents	Met pre-determined acceptance criteria. (Implies results are not significantly affected by common interferents.)
Long term and On-analyzer Stability	Met pre-determined acceptance criteria. (Implies acceptable performance over time and during use on the analyzer.)
Limit of Detection	Met pre-determined acceptance criteria. (Implies ability to detect triglycerides at the lower end of the assay range.)
Specimen Type	Met pre-determined acceptance criteria. (Implies acceptable performance with both serum and plasma.)

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin of the data, retrospective or prospective). This information is typically detailed in the validation and verification reports, which are summarized in the 510(k) but not fully reproduced here.

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

This information is not provided. For this type of in vitro diagnostic device (IVD), ground truth is established through reference methods or comparative studies with an established predicate device, rather than expert interpretation of images or other subjective data. Therefore, "experts" in the context of establishing ground truth for a clinical diagnostic test would typically refer to laboratory professionals performing the reference measurements, for which specific qualifications might not be explicitly stated in the 510(k) summary itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as image analysis, where multiple readers provide opinions that might need to be resolved. For an IVD device measuring a quantitative analyte like triglycerides, the "ground truth" is established by a reference method or predicate device, and differences are analyzed statistically, not through direct adjudication of expert opinions on the test results.

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

An MRMC comparative effectiveness study was not done. This is an In Vitro Diagnostic (IVD) device for measuring triglyceride concentration, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers and AI assistance.

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

This concept is not directly applicable to this device in the way it is typically understood for AI-based algorithms. The device itself performs the measurement (algorithmically via chemical reactions and spectrophotometry). The study implicitly evaluates the "standalone" performance of the modified VITROS Chemistry Products TRIG Slides by comparing its results to a predicate device and ensuring it meets established specifications (accuracy, precision, etc.). There is no "human-in-the-loop" component in the direct measurement process of this specific IVD device.

7. The Type of Ground Truth Used

For this IVD device, the "ground truth" would have been established by:

Reference Methods: Highly accurate and precise laboratory methods for triglyceride measurement.
Predicate Device Comparison: The performance of the modified device was compared to the legally marketed predicate device (VITROS Chemistry Products TRIG Slides cleared on August 3, 1981 (K812029)). This comparison ensures "substantial equivalence" to a device already deemed safe and effective.

The testing considered accuracy, precision, linearity, potential interferents, stability, limit of detection, and specimen type, all of which would be assessed against established scientific and clinical standards, and in comparison to the predicate.

8. The Sample Size for the Training Set

This information is not provided. For a traditional IVD device based on chemical reactions and spectrophotometry, there isn't a "training set" in the machine learning sense. The device's operational parameters (like calibration curves, reaction kinetics) are established through rigorous experimental design and optimization, not by "training" an algorithm on a 'training set' of patient data in the way a modern AI model would be.

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

As explained above, the concept of a "training set" and establishing ground truth for it, as typically applied to AI/ML devices, is not directly applicable here. The device's function is based on established biochemical principles and analytical chemistry, with its design and performance specifications developed through scientific experimentation and engineering.

Summary

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14130332

SECTION 6: 510(k) Summary

MAY 3 1 2013

510(k) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter Information
Name	Ortho-Clinical Diagnostics, Inc.
Address	100 Indigo Creek Drive
	Rochester, New York 14626
Phone number	(585) 453-3962
Fax number	(585) 453-3368
Establishment RegistrationNumber	1319809
Name of contact person	Gaozhen Hang
Date prepared	February 8, 2013
Name of device
Trade or proprietary name	VITROS Chemistry Products TRIG Slides
Common or usual name	Lipase Hydrolysis/Glycerol Kinase Enzyme,Triglycerides
Classification name	Triglyceride test system
Classification panel	Clinical Chemistry
Regulation	21 CFR 862.1705
Product Code(s)	CDT
Legally marketed device(s)to which equivalence isclaimed	The VITROS Chemistry Products TRIG Slides(modified) are substantially equivalent to the VITROSChemistry Products TRIG Slides (current). The FDAcleared the VITROS Chemistry Products TRIG Slideson August 3, 1981 (K812029).

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Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k)

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Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k) ·

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Summary of the technological characteristics of the device compared to thepredicate device
Characteristic	New Device [VITROSTRIG Slide (Modified)]	Predicate [VITROS TRIGSlide (Current) [K812029]
Intended Use	No Change	For in vitro diagnostic useonly.VITROS Chemistry ProductsTRIG Slides quantitativelymeasure triglyceride (TRIG)concentration in serum andplasma using VITROS250/350/950/5,1 FS and 4600Chemistry Systems and theVITROS 5600 IntegratedSystem.
Basic Principle	No Change	Enzymatic Endpoint test typeutilizing reflectancespectrophotometry
Concentrations ofVITROS TRIG SlideReactive Ingredients percm-squared	No Change	Lipase ( Candida rugosa E.C.3.1.1.3) 0.15 UPeroxidase (horseradish rootE.C.1.11.1.7) 0.52 U; glycerolkinase ( Cellulomonas sp.,E.C.2.7.1.30) 0.35 U; L-α-glycerophosphate oxidase( Pediococcus sp., E.C.1.1.3.-)0.19 U; Triton X-100 0.62 mg;2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4-dimenthylaminophenyl)imidazole (leuco dye) 0.04 mg;and adenosine triphosphate0.14 mg.
Sample volume	No Change	5.5 µL
Sample type	No Change	Serum, plasma
Assay Range Serum,Plasma	No Change	10.0-525.0 mg/dL
Incubation time andtemperature	No Change	5 minutes at 37°C

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Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k)

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Summary of design control activities conducted in relation to the device modification

The Ortho-Clinical Diagnostics, Inc. procedure for risk management is based on ISO 14971, Medical Devices - Application of Risk Management to Medical Devices and references CDRH Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.

The risk analysis method used to assess the impact of the device modification was a Hazard Analysis. The following performance characteristics: accuracy, precision, linearity, potential interferents, long term and on-analyzer stability, limit of detection and specimen type were considered for potential hazards. Validation and verification testing were conducted and the modified device met the pre-determined acceptance criteria for all the performance testing. The modification does not negatively impact the performance of the device or the safety and effectiveness of the device.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The information presented in the premarket notification provides a reasonable assurance that the VITROS Chemistry Products TRIG Slides (modified) for use with human serum and plasma is substantially equivalent to the predicate (unmodified VITROS TRIG Slides) and is safe and effective for the stated intended use.

Ortho-Clinical Diagnostics VITROS® Chemistry Product TRIG Slides Special 510(k)

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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 and Human Services. The logo features a stylized symbol with three curved lines, resembling a person embracing another. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2013

Ortho-Clinical Diagnostics, Inc. C/O Gaozhen Hang 100 Indigo Creek Drive ROCHESTER NY 14626-5101

Re: K130332

Trade/Device Name: VITROS Chemistry Products TRIG Slide Regulation Number: 21 CFR 862.1705 Regulation Name: Triglyceride test system Regulatory Class: I, meets limitations of exemption per 21 CFR 862.9(c)(4) Product Code: CDT Dated: May 06, 2013 Received: May 09, 2013

Dear Gaozhen Hang:

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 .- Please note .- CDRH-does not-evaluate information-related to contract-liability warranties." We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for

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the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol G. Benson -S for

Courtney H. Lias, Ph.D. Director, Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

· Enclosure

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Indications for Use

510(k) Number (if known):	K130332
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Device Name:

VITROS® Chemistry Products TRIG Slide

Indications for Use: .

Indications for Use:

For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS® Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

AND/OR Prescription Use X 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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) ___

Ruth A. Chester - S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)_k130332

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Regulation Number and Section

§ 862.1705 Triglyceride test system.

(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.