ACE HDL-C REAGENT

K971526 · Schiapparelli Biosystems, Inc. · LBS · May 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971526
• Device Name: ACE HDL-C REAGENT
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: LBS · Clinical Chemistry
• Decision Date: May 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

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

Device Story

In vitro diagnostic reagent for quantitative determination of HDL cholesterol in human serum. Principle: Homogeneous direct assay. Reagent 1 (polymers/polyanions) binds LDL, VLDL, and chylomicrons, stabilizing them against detergent. Reagent 2 (detergent) solubilizes only HDL particles. Cholesterol enzymes then react with solubilized HDL cholesterol. Used in clinical laboratories; operated by technicians. Output is spectrophotometric measurement (bichromatic 544/692 nm). Results assist clinicians in evaluating coronary heart disease risk and atherosclerosis pathogenesis.

Clinical Evidence

Bench testing only. Performance assessment included within-run precision (< 2.7% CV) and between-run precision (< 4.6% CV). Method correlation vs. CDC reference method showed slope 1.014, intercept 0.13, r=0.986. Correlation vs. Dextran Sulfate precipitation method showed slope 0.991, intercept 0.55, r=0.976. Assay range 2-100 mg/dL.

Technological Characteristics

Homogeneous direct assay. Reagents: Liquid (polyanion, polymer, detergent) and lyophilized (enzymes). Detection: Spectrophotometric (bichromatic 544/692 nm). Temperature: 37°C. Assay system: Automated clinical chemistry analyzer.

Indications for Use

Indicated for the quantitative determination of HDL cholesterol in human serum to assess risk of coronary heart disease and atherosclerosis.

Regulatory Classification

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.

Predicate Devices

• N-geneous™ HDL Cholesterol Reagent (K962186)

Submission Summary (Full Text)

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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: [phone]

#### Contact Person

Steve Dalessio Manager. Quality Assurance and Regulatory Affairs Phone: [phone]

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

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.

### 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

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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 HDL<br>Cholesterol | ACE TM HDL-C Reagent |
| Reference No. | K962186 | TBD |
| Analyte | HDL Cholesterol | HDL Cholesterol |
| Intended Use | Quantitative determination<br>of HDL Cholesterol | Quantitative determination<br>of 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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**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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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.

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.

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

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