LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET

K994110 · Diasorin/American Standard Companies · DFC · Dec 21, 1999 · Immunology

Device Facts

• Record ID: K994110
• Device Name: LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
• Applicant: Diasorin/American Standard Companies
• Product Code: DFC · Immunology
• Decision Date: Dec 21, 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 test kit for the quantitative measurement of human lipoprotein(a) in serum. The device utilizes immunoprecipitin analysis performed on a turbidimetric clinical analyzer (specifically the Hitachi 911). The system measures turbidity changes resulting from antigen-antibody reactions to determine Lp(a) concentration in mg/dL. It is intended for use by clinical laboratory professionals to assist in lipid metabolism disorder evaluation and CHD risk assessment. The output is a quantitative value used by clinicians in conjunction with other patient data to inform clinical decision-making.

Clinical Evidence

Bench testing with clinical samples was performed to validate the performance of the modified device on the Hitachi 911 analyzer. Results demonstrated that the performance characteristics are substantially equivalent to the predicate device.

Technological Characteristics

Immunoprecipitin analysis; turbidimetric measurement; reagent set for use on clinical chemistry analyzers (e.g., Hitachi 911).

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™ III Antibody Reagent Set for Lipoprotein(a)

Submission Summary (Full Text)

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# TEC 2 | BB

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

#### 510(k) Summary 10

K994110
December 3, 1999

| Submitted By: | Judith J. Smith<br>DiaSorin, Inc.<br>Quarry Park Place, Suite 100<br>9175 Guilford Road<br>Columbia, MD 21046 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| December 3, 1999 | |
| Name Of Device: | |
| Trade Name: | Lipoprotein(a) SPQ ^TM 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 ^TM III Antibody Reagent Set for Lipoprotein(a) |
| Device Description: | Lipoprotein(a) Immunological Test Kit |
| Intended Use: | FOR IN VITRO DIAGNOSTIC USE.<br>The SPQ ^TM 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 and<br>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 that of the predicate device. Changes in the labeling and package insert directly reflect the device modification (the additional instrument application for the Hitachi 911).

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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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles arranged in a cascading manner, resembling a series of waves or flowing lines.

BEC 2 | 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K994110

> Trade Name: SPO™ III Test System Antibody Reagent Set for Lp(a) Regulatory Class: II Product Code: DFC Dated: December 3, 1999 Received: December 6, 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 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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### 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 [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 Putman

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: K994110

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

Intended Use/Indications For 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.

L

(Division Sign-Off)
Division of Clinical Laboratory Devices

Cooper

510(k) Number

1994110

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺳﮯ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔ Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)