Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.

Device Description

An aliquot of serum is added to the first reagent which contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent, which is added as part of the second reagent, together with cholesterol enzymes. HDL particles are not stabilized by the polymers and polyanions and become solubilized by the detergent. As a result, only the HDL cholesterol is subject to measurement.

AI/ML Overview

The ACE™ HDL-C Reagent is intended for the quantitative determination of HDL cholesterol in human serum. The study provided focuses on establishing substantial equivalence to a predicate device (N-geneous™ HDL Cholesterol Reagent) and to a CDC reference method, rather than specifically defining explicit acceptance criteria in a regulatory sense for a single-arm study. The performance assessment compares key metrics to both the predicate device and the CDC reference method.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents performance summaries for comparison against a predicate device and a reference method, with the implicit acceptance being that the proposed device performs comparably. The document states that "Based on these data, the Schiapparelli Biosystems ACE™ HDL-C reagent is substantially equivalent to the Centers for Disease Control Reference Method and the predicate device, the Genzyme N-geneous HDL Cholesterol Reagent."

Parameter	Implied "Acceptance Criteria" (from Predicate/CDC)	Proposed Device Performance (ACE™ HDL-C Reagent)
Assay Range	Predicate: 2 mg/dL to 200 mg/dL	2 mg/dL to 100 mg/dL
Precision
Within Run (% CV)	Predicate: < 1.5 %CV	< 2.7 % CV
Between Run (% CV)	Predicate: < 3.8 %CV	< 4.6 %CV
Correlation vs. CDC Ref
Slope	CDC Ref: 1.01	1.014
Intercept	CDC Ref: -3.39	0.13
r	CDC Ref: 0.96	0.986
Correlation vs. Phosphotungstic Acid Ppt
Slope	Predicate: 0.81	N/A (Proposed vs. Dextran Sulfate Ppt)
Intercept	Predicate: 7.82	N/A (Proposed vs. Dextran Sulfate Ppt)
r	Predicate: 0.96	N/A (Proposed vs. Dextran Sulfate Ppt)
Correlation vs. Dextran Sulfate Ppt (Proposed only)	N/A (This is a comparison method for the proposed device)
Slope	N/A	0.991
Intercept	N/A	0.55
r	N/A	0.976

Note: The document directly compares the proposed device to the CDC reference method for slope, intercept, and r. For other correlation, the proposed device is compared against Dextran Sulfate Ppt, while the predicate is compared against Phosphotungstic Acid Ppt. The implied acceptance is that these values should be "comparable" to demonstrate substantial equivalence.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only provides performance summary data (e.g., precision values, correlation statistics).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. The study involves laboratory-based measurements of HDL cholesterol rather than expert interpretation of medical images or other subjective data. Ground truth is established by a reference laboratory method (CDC Reference Method) or comparative chemical precipitation methods.

4. Adjudication method for the test set

This information is not applicable and not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for this chemical 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

This information is not applicable and not provided in the document. This is a submission for a diagnostic reagent for an automated assay, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, a standalone performance assessment was done for the ACE™ HDL-C Reagent, as evidenced by the "Performance Assessment" section. This section details the reagent's assay range, precision (within-run and between-run), and correlation against reference methods. There is no human-in-the-loop component for the direct measurement by this reagent.

7. The type of ground truth used

The ground truth for the performance assessment was established using a CDC Reference Method for cholesterol determination and chemical precipitation methods (specifically Dextran Sulfate Ppt for the proposed device and Phosphotungstic Acid Ppt for the predicate device within the correlation studies).

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or algorithm development. This is a diagnostic reagent, and its performance is evaluated through analytical validation, not a machine learning training process.

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

Not applicable, as there is no "training set" in the context of this device's development as described in the provided summary.

Summary

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510(k) PREMARKET NOTIFICATION Summary of Safety and Effectiveness ACE™ HDL-C Reagent

K971526

In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is tur nou of a S10(k) summary for disclosure to any other persons / companies without specific written authorization from Schiapparelli Biosystems, Inc.

Submitter

Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: (201) 882-8630

Contact Person

Steve Dalessio Manager. Quality Assurance and Regulatory Affairs Phone: (201) 882-8630

Device Names

ACE™ HDL-C Reagent Proprietary Name: Homogeneous assay for high density lipoprotein cholesterol Common Name: Classification Name: High density lipoprotein cholesterol test

Predicate Device

Genzyme Corporation's - N-geneous™ HDL Cholesterol Reagent [510(k) Number K962186]

Device Description

Intended Use of the Device

ACE™ HDL-C Reagent is intended for use in the quantitative determination of HDL cholesterol in human serum.

HHDL510K.WPS

Image /page/0/Picture/17 description: The image shows the date May 21, 1997. The month is written in all caps, and the day and year are written in numerals. The text is written in a bold, sans-serif font. The image is a close-up of the date, and the background is white.

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Summary of Safety and Effectiveness ACE™ HDL-C Reagent

COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICE

PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
Trade Name	N-geneous TM HDLCholesterol	ACE TM HDL-C Reagent
Reference No.	K962186	TBD
Analyte	HDL Cholesterol	HDL Cholesterol
Intended Use	Quantitative determinationof HDL Cholesterol	Quantitative determinationof HDL Cholesterol
Methodology	Homogeneous; Direct	Homogeneous; Direct
Reagents
Reagent 1	Liquid; Polyanion, Polymer	Liquid; Polyanion, Polymer
Volume	300 uL	300 uL
Reagent 2 (Diluent)	Liquid; Detergent	Liquid; Detergent
Reagent 3 (Recon with Rgt 2)	Lyophilized; Enzymes	Lyophilized; Enzymes
Volume	100 uL	100 uL
Specimen
Type	Serum and Plasma	Serum
Volume	3 uL	3 uL
Assay System
Reagent 1 + sample	Incubate 300s	Incubate 300s
Reagent 3	Incubate 24 - 300s	Incubate 300s
Temperature	37C	37C
Detection Method
Type	Spectrophotometric	Spectrophotometric
Wavelength, nm	Bichromatic: 546/660	Bichromatic: 544/692

HHDL510K.WPS

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Summary of Safety and Effectiveness ACETM HDL-C Reagent

Performance Assessment

Non-clinical test results submitted in the premarket notification include within-run and between run precision and method correlation. Following is a data summary.

PARAMETER	PREDICATE DEVICE	PROPOSED DEVICE
Performance Summary
Assay Range	2 mg/dL to 200 mg/dL	2 mg/dL to 100 mg/dL
Precision
Within Run	< 1.5 %CV	< 2.7 % CV
Between Run	< 3.8 %CV	< 4.6 %CV
Correlation vs CDC Ref
Slope	1.01	1.014
Intercept	-3.39	0.13
r	0.96	0.986
Correlation vs	Phosphotungstic Acid Ppt	Dextran Sulfate Ppt
Slope	0.81	0.991
Intercept	7.82	0.55
r	0.96	0.976

Based on these data , the Schiapparelli Biosystems ACE™ HDL-C reagent is substantially equivalent to the Centers for Disease Control Reference Method and the predicate device, the Genzyme N-geneous HDL Cholesterol Reagent. On this basis, the reagent is determined to be safe and effective for its intended use. Performance details are included in the reagent product labeling.

HHDL510K.WPS

(

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Image /page/3/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle, following its curvature.

ublic Health Service

MAY 2 | 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Steve Dalessio Manager, Quality Assurance & Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, New Jersey 0.7004 - - - - - - - -

K971526 Re : ACE HDL-C Reagent Regulatory Class: I & II Product Code: LBS, JIX, JJY Dated: April 23, 1997 Received: April 28, 1997

Dear Mr. Dalessio:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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15/97	15:39
301 594 5941

Page 1 of 1

510(k) Number (if known):_

Device Name:_ACE HDL-C REAGENT

Indications For Use:

This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum.

signature

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971526

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use) (Per 21 CFR 801.109)

: "

Article Carante

Over-The-Counter Use_

(Optional Format 1-2-96)

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.