(16 days)
Not Found
Not Found
No
The summary describes a turbidimetric immunoassay for measuring lipoprotein(a) and does not mention any AI or ML components.
No
Explanation: The device is for in vitro diagnostic use, specifically for the quantitative determination of human lipoprotein(a) to evaluate disorders of lipid metabolism and assess coronary heart disease, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "FOR IN VITRO DIAGNOSTIC USE." and describes its purpose for quantitative determination in human serum to evaluate disorders and assess coronary heart disease, which are diagnostic activities.
No
The device is described as an "Immunological Test Kit" and a "Reagent Set," indicating it is a physical kit containing reagents for in vitro diagnostic testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "FOR IN VITRO DIAGNOSTIC USE." This is the primary indicator that the device is intended for use outside of the body to examine specimens for diagnostic purposes.
N/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 turbidity 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.
Product codes
82DFC
Device Description
Lipoprotein(a) Immunological Test Kit
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Bench Testing With Clinical Samples: Bench testing with clinical samples demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device.
Key Metrics
Not Found
Predicate Device(s)
SPQTM II Antibody Reagent Set for Lipoprotein(a)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Special 510(k): Device Modification: Lp(a) SPQ™ III Antibody Reagent Set
10 510(k) Summary
October 29, 1999
| Submitted By: | Judith J. Smith
DiaSorin, Inc.
Quarry Park Place, Suite 100
9175 Guilford Road
Columbia, MD 21046 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name Of Device:
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.
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. |
| Technological
Comparison: | The modified device has the same technological basis as the
predicate device. |
| Labeling Comparison: | The labeling of the modified device is substantially equivalent to
that of the predicate device. Changes in labeling directly reflect the
device modification (additional antibody and reduced reaction time). |
1
| Bench Testing
With Clinical Samples: | Bench testing with clinical samples demonstrated that the
performance characteristics of the modified device were
substantially equivalent to those of the predicate device. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusions from
Testing: | The modified device is substantially equivalent to the predicate
device. |
·
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.
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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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 regulation (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/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
4
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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