For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.

For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.

Device Description

The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry analyzer intended for use in the in vitro determination of various analytes in human specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:

The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay.
The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924).
Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

AI/ML Overview

The provided text describes the acceptance criteria and study for the VITROS Chemistry Products dLDL Reagent and Performance Verifiers. However, it is a 510(k) summary for an in vitro diagnostic device (IVD), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo clinical studies often associated with AI/ML devices or complex medical devices. Therefore, some of the information requested, especially regarding AI/ML-specific metrics like MRMC studies, sample sizes for AI training sets, ground truth establishment for training, and expert qualifications/adjudication for test sets, is not applicable or not present in this type of document.

Here's the available information extracted and organized according to your prompt:

1. Table of acceptance criteria and the reported device performance

For the VITROS dLDL Reagent (new device) compared to the Polymedco Lipi+Plus Direct LDL assay (predicate device):

Characteristic	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (VITROS dLDL)
Correlation with Predicate	Strong linear correlation and high correlation coefficient	VITROS dLDL = 1.031 x X - 3.81 (mg/dL), with a correlation coefficient of 0.9908
Reportable Range	Consistent with predicate's intended use	30 - 350 mg/dL
Specimen Pretreatment	None Required (Homogeneous assay)	None Required (Homogeneous assay)
Basic Principle	Elimination enzymatic test	Elimination enzymatic test
Reagents	Liquid ready to use	Liquid ready to use
Instrumentation	(Not an acceptance criterion for the reagent itself, but specified as the intended platform)	VITROS 5,1 FS Chemistry System
Sample Type	Serum and Plasma	Serum and Plasma (heparin)
Reaction Steps	Step 1: Elimination, Step 2: Measurement	Step 1: Elimination, Step 2: Measurement
Incubation Temperature	37 °C	37 °C
Additional Studies (Summarized)	Acceptable precision, specificity, linearity, and expected values	Studies performed to determine precision, specificity, linearity, and expected values (results summarized in Instructions for Use, not detailed here)

For the VITROS Chemistry Products Performance Verifiers I and II (new device) compared to the VITROS Chemistry Products Performance Verifiers (predicate device):

Characteristic	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (VITROS dLDL)
Intended Use	Monitor performance on VITROS Chemistry Systems	Monitor performance on VITROS Chemistry Systems (New additional intended use: to monitor performance of LDL Cholesterol on the VITROS 5,1 FS Chemistry System) - Note: The "new additional intended use" is a difference, but typically deemed acceptable if performance is still substantially equivalent.
Matrix of Performance Verifiers	Base matrix of freeze-dried human serum with added enzymes, electrolytes, stabilizers, preservatives, and other organic analytes	Base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added.
Performance Verifier Levels	Low and High	Low and High

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

Sample Size for Test Set: The document states that equivalence was demonstrated using "patient samples" but does not specify the number of samples used for the correlation study or other performance studies (precision, specificity, linearity).
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The data is described as using "commercially available reagents along with patient samples", suggesting data from clinical laboratory testing.

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)

This is an IVD device measuring a biochemical analyte. The "ground truth" for the test set is established by the predicate device's measurement (Polymedco Lipi+Plus Direct LDL assay). Therefore, the concept of "experts" to establish ground truth in the sense of image interpretation or diagnostic adjudication is not applicable here. The analytical measurement of the predicate device serves as the reference.

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

Not applicable for an IVD device measuring a biochemical analyte against a predicate assay.

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 an in vitro diagnostic assay, not an AI/ML diagnostic aid for human readers.

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

Yes, the studies described are standalone performance evaluations of the VITROS Chemistry Products dLDL Reagent and Performance Verifiers. The device measures LDL cholesterol directly and its performance is assessed analytically, independent of human interpretation or an operator-in-the-loop.

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

The primary ground truth for the correlation study of the VITROS dLDL assay is the measurement obtained from the predicate device, the Polymedco Lipi+Plus Direct LDL assay, on the Dade Dimension clinical chemistry analyzer. For other performance characteristics (precision, linearity), the "ground truth" would be defined by standard laboratory reference methods or expected values.

8. The sample size for the training set

This document describes a traditional IVD. The concept of a distinct "training set" for an AI/ML algorithm is not applicable here. The reagents and assay development follow established chemical and enzymatic principles, and their performance is subsequently validated using patient samples.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm.

Summary

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Chapter 1 - 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: KOY 1720

Ortho-Clinical Diagnostics, Inc. Submitter 1. name, 100 Indigo Creek Drive address, Rochester, New York 14626-5101 (585) 453-4041 contact
Contact Person: Marlene A. Hanna
Date 510(k) prepared: June 23, 2004 2. Preparation date
Trade or Proprietary Name: 3. Device VITROS Chemistry Products dLDL Reagent name VITROS Chemistry Products Calibrator Kit 19 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products Performance Verifiers I and II

Common Name: Direct LDL assay

Classification Name: Lipoprotein test system (862.1475): Class: I: The Clinical Chemistry and Toxicology Panel of the FDA has placed lipoprotein test systems in Class I. Since this device is an in vitro device intended for use in assessing the risk of cardiovascular diseases, it meets the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

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.

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510(k) Summary, Continued

a. The VITROS Chemistry Products dLDL assay is substantially equivalent to the 4. Predicate Polymedco Lipi+Plus Direct LDL assay. Device
b. The VITROS Chemistry Products Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II.
The VITROS 5.1 FS Chemistry System is a fully automated clinical chemistry 5. Device analyzer intended for use in the in vitro determination of various analytes in human description specimens (serum, plasma, urine, and cerebrospinal fluid). The VITROS 5,1 FS is designed for use with VITROS Chemistry Products MicroTip and Thin Film assays.
The system is comprised of four main elements:
1. The VITROS 5,1 FS Chemistry System instrumentation, which provides automated use of the chemistry reagents. The VITROS 5.1 FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924).
1. The VITROS Chemistry Products MicroTip range of liquid reagent products (in this case VITROS Chemistry Products dLDL Reagent, VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1, VITROS Chemistry Products Performance Verifiers I and II), which are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS dLDL assay.
1. The VITROS Chemistry Products Thin Film range of dry products, which are dry, multilayered, analytical elements, coated on polyester supports. The thin film products each have there own 510(k) clearance numbers and were cleared for market for use on the VITROS 5.1 FS Chemistry System through submission of information required by the ODE Guidance Document: "Data For Commercialization Of Original Equipment Manufacturer, Secondary and Generic Reagents For Automated Analyzers". The required information was provided in the VITROS 5.1 FS Chemistry System premarket notification (K031924).
1. Common reagents used by multiple assays on the VITROS System (in this case, VITROS Chemistry Products FS Diluent Pack 2 and VITROS Chemistry Products FS Reconstitution Diluent).

The VITROS System and reagents are designed specifically for use with the VITROS Chemistry Products range of products.

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a. VITROS Chemistry Products dLDL Reagent: For in vitro diagnostic use only. 6. Device intended The VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density use Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentration.

b. VITROS Chemistry Products Calibrator Kit 19 and VITROS Chemistry Products FS Calibrator 1: For in vitro diagnostic use only. The VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.

c. VITROS Chemistry Products Performance Verifiers I and II: For in vitro diagnostic use only. The VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.

7. Comparison to predicate device(s):

Reagent Pack and Calibrators

The VITROS Chemistry Products dLDL Reagent and VITROS Chemistry Products Calibrator Kit 19 and FS Calibrator 1 are substantially equivalent to the Polymedco Lipi+Plus Direct LDL assay (predicate device) which was cleared by the FDA (K020852) for IVD use.

The relationship between the VITROS dLDL and the predicate device, determined by least squares linear regression, is:

VITROS dLDL = 1.031 x X - 3.81 (mg/dL), with a correlation coefficient of 0.9908, where X is the Polymedco Lipi+Plus Direct LDL assay on a Dade Dimension clinical chemistry analyzer.

In addition to the above mentioned correlation study, studies were performed to determine the precision, specificity, linearity, and expected values of the VITROS dLDL assay, (refer to the VITROS dLDL Reagent Instructions for Use for summaries of the results of these studies).

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510(k) Summary, Continued

Table 1 lists the characteristics of the assays performed using the VITROS dLDL assay and the Polymedco Lipi+Plus Direct LDL assay.

DeviceCharacteristic	VITROS dLDL(New device)	dLDL(Predicate device)
Reportable Range	30 - 350 mg/ dL	0 - 1000 mg/dL
Specimen Pretreatment	None Required:Homogeneous assay	None Required:Homogeneous assay
Basic Principle	Elimination enzymatic test	Elimination enzymatic test
Reagents	Liquid ready to use	Liquid ready to use
Instrumentation	VITROS 5,1 FS ChemistrySystem	Dade Dimension clinicalchemistry system
Sample Type	Serum and Plasma (heparin)	Serum and Plasma (heparinand EDTA)
Reaction steps	Step 1: EliminationStep 2: Measurement	Step 1: EliminationStep 2: Measurement
IncubationTemperature	37 °C	37 °C

Table 1 lists the characteristics of the VITROS dLDL (new device) and the dLDL Table 1

Performance Verifiers

The VITROS Chemistry Products Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers (predicate device) which were cleared by the FDA (K904768) for IVD use.

Table 2

Table 2 lists the similarities and differences of the device characteristics between the VITROS Performance Verifiers with the predicate device, VITROS Performance Verifiers I and II.

DeviceCharacteristic	VITROS dLDL (New device)	dLDL (Predicate device)
Intended Use	VITROS Performance Verifier is an assayed control used to monitor performance on VITROS Chemistry Systems. (New additional intended use: to monitor performance of LDL Cholesterol on the VITROS 5,1 FS Chemistry System.)	VITROS Performance Verifier is an assayed control used to monitor performance on VITROS Chemistry Systems.
Matrix ofPerformanceVerifiers	A base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added.	A base matrix of freeze-dried human serum to which enzymes, electrolytes, stabilizers, preservatives and other organic analytes have been added.
PerformanceVerifier Levels	Low and High	Low and High

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510(k) Summary, Continued

The data presented in the premarket notification provide a reasonable assurance Conclusions that the VITROS dLDL assay and the VITROS Chemistry Products Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices. The data in this premarket notification demonstrate that the performance of the VITROS dLDL assay and Performance Verifiers are substantially equivalent to the cleared predicate device(s).

Equivalence to predicate(s) was demonstrated using commercially available reagents along with patient samples.

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Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a symbol resembling a stylized human figure with three wavy lines extending from its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

AUG 2 5 2004

K041720 Re:

Trade/Device Name: VIRTOS Chemistry Products dLDL Reagent VIRTOS Chemistry Products Calibrator Kit 19 VIRTOS Chemistry Products FS Calibrator 1 VIRTOS Chemistry Products Performance Verifiers I and II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX, MRR, Dated: June 23, 2004 Received: June 24, 2004

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.

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) 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.

Jean M. Corgan, MS, DVM.

Jean M. Cooper, MS, 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):	K041720
Device Name(s):	VITROS Chemistry Products dLDL ReagentVITROS Chemistry Products Calibrator Kit 19VITROS Chemistry Products FS Calibrator 1VITROS Chemistry Products Performance Verifiers I and II
Indications for Use:	For in vitro diagnostic use only. VITROS Chemistry Products dLDL Reagent is used to quantitatively measure LDL Cholesterol (LDLC) concentration in serum and plasma. Low Density Lipoprotein (LDL) cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with higher LDL cholesterol concentrations.For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 19 is used in conjunction with VITROS FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of HDL and LDL cholesterol using VITROS dHDL and dLDL Reagents.For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers I and II are assayed controls used to monitor performance on VITROS Chemistry Systems.
Prescription Use(Per 21 CFR 801 Subpart D)	AND/OR &p>

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Caul Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041720

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.