(15 days)
FOR IN VITRO DIAGNOSTIC USE. The SPQ TM 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.
Lipoprotein(a) Immunological Test Kit
The provided text describes a Special 510(k) for a device modification: Lp(a) SPQ™ III Antibody Reagent Set. The purpose of the submission is to demonstrate that the modified device, which includes an additional instrument application for the Hitachi 911 analyzer, is substantially equivalent to the predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, the overall acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device. The performance is reported qualitatively.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to the predicate device | "Bench testing with clinical samples demonstrated that the performance characteristics of the modified device were substantially equivalent to those of the predicate device." |
| Same technological basis as the predicate device | "The modified device has the same technological basis as the predicate device." |
| Labeling substantially equivalent to the predicate device | "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)." |
| Quantitative determination of human lipoprotein(a) in mg/dL | Intended use is for "quantitative determination of human lipoprotein(a) in mg/dL" |
| Immunoprecipitin analysis using a turbidimetric clinical analyzer | Intended use specifies "immunoprecipitin analysis using a turbidimetric clinical analyzer." (The modification adds compatibility with Hitachi 911). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that "Bench testing with clinical samples" was performed. However, it does not specify the number of clinical samples used in this testing.
- Data Provenance: The document does not specify the country of origin of the data. Given the "FOR IN VITRO DIAGNOSTIC USE" and "human serum" description, it can be inferred that the data is from human subjects, likely in a clinical setting. It is a retrospective or prospective study is not explicitly stated, but "bench testing with clinical samples" suggests a study where samples were analyzed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For this type of in vitro diagnostic device, the ground truth would typically be established by a reference method or a clinically accepted laboratory standard, not by expert consensus in the traditional sense of image interpretation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. For an in vitro diagnostic assay, adjudication usually refers to resolving discrepancies in expert interpretations (e.g., in imaging studies). For a quantitative assay, the performance is typically compared against a reference method or established statistical measures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study is typically relevant for interpretative devices (e.g., medical imaging AI) where human readers are involved. This device is an in vitro diagnostic (IVD) reagent set for quantitative measurement, which falls into a different category of performance assessment. The comparison is between the modified device and the predicate device's performance, not human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device described is an in vitro diagnostic (IVD) reagent set, not an algorithm or AI. It is designed for "immunoprecipitin analysis using a turbidimetric clinical analyzer." Therefore, the concept of "standalone (algorithm only)" performance does not directly apply as it would for a software-based AI device. The performance evaluated is the measurement capability of the reagent set on an analyzer, which is inherently a "standalone" measurement in terms clinical context but not in the AI context.
7. The Type of Ground Truth Used
The type of ground truth used is implied to be quantitative measurements of human lipoprotein(a). For IVD devices, "ground truth" is typically established by:
- Comparison to a reference method (e.g., a more sensitive, specific, or established laboratory test).
- Correlation with clinically established standards or diagnostic criteria.
- In this case, the comparison is made against the predicate device's performance, implying the predicate device's results serve as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI components. This device is a chemical reagent set for a laboratory assay.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (because the device is an IVD reagent set, not an AI/ML device), this question is not applicable.
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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. SmithDiaSorin, Inc.Quarry Park Place, Suite 1009175 Guilford RoadColumbia, 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.The SPQ TM 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 metabolism andto 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 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 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 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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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 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)
§ 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).