(16 days)
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.
Lipoprotein(a) Immunological Test Kit
The provided text describes a Special 510(k) for a device modification: the Lp(a) SPQ™ III Antibody Reagent Set. This submission is for a modification to an existing device, and the primary goal is to demonstrate "substantial equivalence" to a predicate device, rather than proving novel clinical efficacy. Therefore, the information typically found in a study proving acceptance criteria for a new device might be limited or presented differently.
Based on the provided text, here's an analysis of the acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (SPQ™ II Antibody Reagent Set for Lipoprotein(a)) in performance characteristics. | "Bench testing with clinical samples demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device." |
| Continued intended use for quantitative determination of human lipoprotein(a) in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer to evaluate disorders of lipid metabolism and assess coronary heart disease (CHD) in male Caucasian populations. | The intended use remains the same as the predicate device. |
| Technological basis remains the same. | "The modified device has the same technological basis as the predicate device." |
| Labeling changes directly reflect device modification (additional antibody and reduced reaction time) and are substantially equivalent. | "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)." |
Note on Acceptance Criteria: For a 510(k) modification aiming for substantial equivalence, the "acceptance criteria" are not typically quantitative performance metrics like sensitivity and specificity for a diagnostic claim (unless a new diagnostic claim is being made). Instead, the primary acceptance criterion is whether the modified device performs comparably to the predicate device, demonstrating that the changes do not introduce new questions of safety or effectiveness. The text explicitly states that the device's performance was "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "bench testing with clinical samples," but the number of samples is not provided.
- Data Provenance: "Clinical samples" are mentioned, implying human samples. The country of origin and whether the data was retrospective or prospective are not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not specified. The study focuses on comparing the modified device to a predicate device, not on establishing a new ground truth or diagnostic accuracy against a gold standard that would typically involve expert consensus. The "ground truth" here would be the results obtained by the predicate device.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. As the study is a comparison to a predicate device rather than an evaluation against a clinical ground truth requiring interpretation, an adjudication method for expert consensus is not relevant or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) reagent set for quantitative determination, not an imaging or interpretive device that would involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device type.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, implicitly. The device itself is a reagent set for an automated turbidimetric clinical analyzer. Its performance is inherent to the reagent-analyzer combination, and it operates autonomously without human interpretation playing a direct role in the measurement of Lp(a) levels. Humans operate the analyzer, but the 'performance' refers to the analytical accuracy of the test itself. The clinical samples were tested against the predicate device's results.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the results obtained from the predicate device, the SPQ™ II Antibody Reagent Set for Lipoprotein(a). The study's aim was to demonstrate analytical substantial equivalence, meaning the modified device should yield comparable results to the established predicate device on the same "clinical samples."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/not specified. This device is a reagent set, not an AI algorithm that requires a training set in the conventional sense. The "bench testing" mentioned refers to analytical validation.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Established: Not applicable/not specified. (See point 8)
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Special 510(k): Device Modification: Lp(a) SPQ™ III Antibody Reagent Set
10 510(k) Summary
October 29, 1999
| Submitted By: | Judith J. SmithDiaSorin, Inc.Quarry Park Place, Suite 1009175 Guilford RoadColumbia, 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 thequantitative determination of human lipoprotein(a) in mg/dL inhuman serum by immunoprecipitin analysis using a turbidimetricclinical analyzer. The measurement of Lp(a) is indicated for use inconjunction with clinical evaluation, patient risk assessment andother lipoprotein tests to evaluate disorders of lipid metabolismand to assess coronary heart disease (CHD) in male Caucasianpopulations. |
| TechnologicalComparison: | The modified device has the same technological basis as thepredicate device. |
| Labeling Comparison: | The labeling of the modified device is substantially equivalent tothat of the predicate device. Changes in labeling directly reflect thedevice modification (additional antibody and reduced reaction time). |
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| Bench TestingWith Clinical Samples: | Bench testing with clinical samples demonstrated that theperformance characteristics of the modified device weresubstantially equivalent to those of the predicate device. |
|---|---|
| Conclusions fromTesting: | The modified device is substantially equivalent to the predicatedevice. |
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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 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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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
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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
(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
§ 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).