LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

K993669 · DiaSorin, Inc. · DFC · Nov 17, 1999 · Immunology

Device Facts

• Record ID: K993669
• Device Name: LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
• Applicant: DiaSorin, Inc.
• Product Code: DFC · Immunology
• Decision Date: Nov 17, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5600
• Device Class: Class 2

Intended Use

FOR IN VITRO DIAGNOSTIC USE. The SPQ™ Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use in conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests to evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) in male Caucasian populations.

Device Story

The SPQ™ III Antibody Reagent Set is an in vitro diagnostic kit for measuring human lipoprotein(a) (Lp(a)) in serum. It utilizes immunoprecipitin analysis on a turbidimetric clinical analyzer. The device functions by reacting patient serum with specific antibodies to form immune complexes, which are then measured via turbidity to quantify Lp(a) concentration in mg/dL. It is intended for use in clinical laboratory settings by trained personnel. The output provides a quantitative value used by clinicians alongside other lipoprotein tests and clinical evaluations to assess lipid metabolism disorders and coronary heart disease risk in male Caucasian populations.

Clinical Evidence

Bench testing with clinical samples was performed to compare the modified device against the predicate. Results demonstrated that the performance characteristics of the modified device are substantially equivalent to the predicate device.

Technological Characteristics

Immunological test kit for quantitative determination of Lp(a). Principle: Immunoprecipitin analysis using turbidimetric clinical analyzer. Modification includes additional antibody and reduced reaction time compared to the predicate.

Indications for Use

Indicated for quantitative determination of human lipoprotein(a) in serum to evaluate lipid metabolism disorders and assess coronary heart disease (CHD) risk in male Caucasian populations.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Predicate Devices

• SPQ™ II Antibody Reagent Set for Lipoprotein(a)

Submission Summary (Full Text)

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K993669

Special 510(k): Device Modification: Lp(a) SPQ™ III Antibody Reagent Set

# 10 510(k) Summary

October 29, 1999

| Submitted By: | Judith J. Smith<br>DiaSorin, Inc.<br>Quarry Park Place, Suite 100<br>9175 Guilford Road<br>Columbia, MD 21046 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name Of Device:<br>Trade Name: | Lipoprotein(a) SPQ™ III Antibody Reagent Set |
| Common Name: | Lipoprotein(a) Immunological Test Kit |
| Classification Name: | Lipoprotein(a), antigen, antiserum, control (82DFC) |
| Device Classification | Class II |
| Predicate Device: | SPQ™ II Antibody Reagent Set for Lipoprotein(a) |
| Device Description: | Lipoprotein(a) Immunological Test Kit |
| Intended Use: | FOR IN VITRO DIAGNOSTIC USE.<br>The SPQ™ Antibody Reagent Set for Lp(a) is designed for the<br>quantitative determination of human lipoprotein(a) in mg/dL in<br>human serum by immunoprecipitin analysis using a turbidimetric<br>clinical analyzer. The measurement of Lp(a) is indicated for use in<br>conjunction with clinical evaluation, patient risk assessment and<br>other lipoprotein tests to evaluate disorders of lipid metabolism<br>and to assess coronary heart disease (CHD) in male Caucasian<br>populations. |
| Technological<br>Comparison: | The modified device has the same technological basis as the<br>predicate device. |
| Labeling Comparison: | The labeling of the modified device is substantially equivalent to<br>that of the predicate device. Changes in labeling directly reflect the<br>device modification (additional antibody and reduced reaction time). |

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| Bench Testing<br>With Clinical Samples: | Bench testing with clinical samples demonstrated that the<br>performance characteristics of the modified device were<br>substantially equivalent to those of the predicate device. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions from<br>Testing: | The modified device is substantially equivalent to the predicate<br>device. |

·

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 17 1999

Ms. Judith J. Smith Vice President. Worldwide Regulatory Affairs and Quality Systems Diasorin Inc. 9175 Guilford Road, Suite 100 Quarry Park Place Columbia, Maryland 21046

Re: K993669

> Trade Name: SPOTM III Test System Antibody Reagent Set for Lp(a) Regulatory Class: II Product Code: DFC Dated: October 29, 1999 Received: November 1, 1999

Dear Ms. Smith:

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 reguirements 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 OS 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 Sutman

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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## 4 Intended Use/Indications For Use

510(k) Number: K993(do9

Device Name: SPQ™ III Test System Antibody Reagent Set for Lp(a)

Intended Use/Indications For Use:

### FOR IN VITRO DIAGNOSTIC USE.

The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determinatior of human lipoprotein(a) in mg/dL in human serum by immunoprecipitin analysis using દ turbidimetric clinical analyzer. The measurement of Lp(a) is indicated for use ir conjunction with clinical evaluation, patient risk assessment and other lipoprotein tests tc evaluate disorders of lipid metabolism and to assess coronary heart disease (CHD) ir male Caucasian populations.

Jean Cooper

(Division Sign-Off)
Division of Clin
510(k) Numbe: K993669

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use /*_ OR Over-The-Counter Use /*_ (Per 21 CFR 801.109)

(Optional Format 1-2-96