ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS

K991733 · Schiapparelli Biosystems, Inc. · MRR · Jul 13, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991733
• Device Name: ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: MRR · Clinical Chemistry
• Decision Date: Jul 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1475
• Device Class: Class 1

Intended Use

ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system. LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay. LDL-C Controls are intended to monitor the performance of the ACE® LDL-C Assay. The measurement of LDL cholesterol is a factor in the pathogenesis of atherosclerosis and coronary artery disease.

Device Story

ACE® LDL-C Reagent is a homogeneous, direct assay for quantitative determination of LDL cholesterol in human serum. Input: serum sample. Process: two-reagent system; first reagent contains detergent to solubilize non-LDL lipoproteins and enzymes to consume non-LDL cholesterol; second reagent contains detergent to release LDL lipoproteins; enzyme reaction with LDL cholesterol and chromogenic coupler produces color proportional to LDL concentration. Output: spectrophotometric measurement (544/692 nm) of color intensity. Used in clinical laboratory settings on the ACE® clinical chemistry system; operated by laboratory technicians. Results assist clinicians in evaluating atherosclerosis and coronary artery disease risk.

Clinical Evidence

Bench testing only. Performance assessment included within-run (≤ 2.6% CV) and between-run (≤ 3.2% CV) precision. Method correlation studies (n=70 vs Hitachi 911; n=66 vs Friedewald calculation) showed r=0.9747 and r=0.9728 respectively. No clinical patient outcome data provided.

Technological Characteristics

Homogeneous, direct enzymatic assay. Reagents: liquid detergent and enzymes. Detection: spectrophotometric (bichromatic 544/692 nm). System: ACE® clinical chemistry system. Temperature: 37°C. Sample: serum.

Indications for Use

Indicated for quantitative determination of LDL cholesterol in human serum to assess factors in the pathogenesis of atherosclerosis and coronary artery disease.

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

• Genzyme N-geneous® LDL Cholesterol Reagent (K971573)
• Genzyme N-geneous® LDL Cholesterol Calibrator
• Genzyme LDL Control Set

Submission Summary (Full Text)

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### JUL 13 1999

K991733

## 510(k) PREMARKET NOTIFICATION ACF® LDL-C Reagent

### SUMMARY OF SAFETY AND EFFECTIVENESS

In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(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

Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: [phone]

### Device Names

| Proprietary Name: | ACE® LDL-C Reagent<br>LDL-C Calibrator<br>LDL-C Controls |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous assay for low density lipoprotein cholesterol |
| Classification Name: | Low density lipoprotein cholesterol test<br>Calibrator, Primary<br>Low density lipoprotein cholesterol control |
| Predicate Device: | Genzyme N-geneous® LDL Cholesterol Reagent<br>[510(k) Number K971573]<br>Genzyme N-geneous® LDL Cholesterol Calibrator<br>Genzyme LDL Control Set |

### Device Description

The ACE® LDL-C Reagent contains two reagents. An aliquot of serum is added to the first reagent, which contains a unique detergent that selectively solubilizes the non LDL lipoproteins. Enzymes also present in the first reagent consume the cholesterol in a non color forming reaction. The second reagent contains another detergent that releases the remaining LDL lipoproteins. The enzyme reaction with LDL cholesterol, in the presence of a chromogenic coupler, produces color that is directly proportional to the amount of LDL cholesterol in the sample.

### Intended Use of the Device

ACE® LDL-C Reagent is intended for use in the quantitative determination of low density lipoprotein cholesterol in human serum.

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# 510(k) PREMARKET NOTIFICATION ACE® LDL-C Reagent

## SUMMARY OF SAFETY AND EFFECTIVENESS

## COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|----------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| Trade Name | Genzyme N-geneous® LDL Cholesterol<br>Reagent | ACE® LDL-C Reagent |
| Reference No. | K971573 | TBD |
| Analyte | LDL cholesterol | LDL cholesterol |
| Intended Use | Quantitative determination of<br>LDL cholesterol | Quantitative determination of<br>LDL cholesterol |
| Methodology | Homogeneous, Direct | Homogeneous, Direct |
| Reagents<br>Reagent 1<br>Volume | Liquid; Detergent, Enzymes<br>300 µL | Liquid; Detergent, Enzymes<br>300 µL |
| Reagent 2<br>Volume | Liquid; Detergent, Chromogenic coupler<br>100 µL | Liquid; Detergent, Chromogenic coupler<br>100 µL |
| Specimen<br>Type<br>Volume | Serum and plasma<br>3 µL | Serum<br>3 µL |
| Assay System<br>Reagent 1 + Sample<br>Reagent 2<br>Temperature | Incubate 300 sec and Read<br>Read at 300 sec<br>37 °C | Incubate 300 sec and Read<br>Read at 300 sec<br>37 °C |
| Detection Method<br>Type<br>Wavelength, nm | Spectrophotometric<br>Bichromatic: 546/660 | Spectrophotometric<br>Bichromatic: 544/692 |

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## 510(k) PREMARKET NOTIFICATION ACE® LDL-C Reagent

## SUMMARY OF SAFETY AND EFFECTIVENESS

### 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<br>Assay Range<br>Precision<br>Within Run<br>Between Run | 6.6 mg/dL to 992 mg/dL<br>≤ 0.73 %CV<br>≤ 2.27 %CV | 3 mg/dL to 800 mg/dL<br>≤ 2.6 %CV<br>≤ 3.2 %CV |
| Correlation vs | Reference method (Ultracentrifugation) | Hitachi 911 |
| Slope | 0.95 | 1.111 |
| Intercept | +3.02 | -15.5 |
| r | 0.96 | 0.9747 |
| n | 54 | 70 |
| Correlation vs | Immunoseparation method | Friedewald calculation |
| Slope | 0.94 | 1.09 |
| Intercept | +4.46 | -17.8 |
| r | 0.97 | 0.9728 |
| n | 92 | 66 |

Based on these data, the Schiapparelli Biosystems ACE® LDL-C Reagent is substantially equivalent to the predicate device Genzyme N-geneous® LDL 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.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 13 1999

Mr. Steven Dalessio Manager, Ouality Assurance/Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield. New Jersey 07004

Re: K991733

> Trade Name: ACE® LDL-C Reagent Regulatory Class: I reserved (Product codes: MRR, JJX) II (Product code: JIS) Dated: May 20, 1999 Received: May 21, 1999

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 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). 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulation (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/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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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Page 1 of

510(k) Number (if known): K991733

ACE® LDL-C Reagent Device Name:

Indications For Use:

ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system.

LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay.

LDL-C Controls are intended to monitor the performance of the ACE® LDL-C
Assav Assay.

The measurement of LDL cholesterol is a factor in the pathogenesis of
atherosclerosis and coronary artery disease atherosclerosis and coronary artery disease.

Jean looper

(Division Sign-Off) Division of Clinical Laboratory Devices 11,2 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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OR

Over-The-Counter Use

(Optional Format 1-2-96)

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