(241 days)
Strategic Diagnostics Macra Lp(a)
Not Found
No
The device description details a standard turbidimetric immunoassay method using a clinical analyzer. There is no mention of AI, ML, or any computational methods beyond standard data reduction for generating a calibration curve and interpolating concentrations. The performance studies focus on clinical correlation, recovery, and reproducibility, which are typical for this type of assay and do not suggest the use of AI/ML.
No.
This device is an in vitro diagnostic (IVD) test designed to quantitatively measure lipoprotein(a) in human serum to assess coronary heart disease risk. It does not provide any treatment or therapeutic intervention.
Yes
The device "evaluates disorders of lipid metabolism and to assess coronary heart disease (CHD)" by "quantitative determination of human lipoprotein(a) in human serum". This fits the definition of a diagnostic device.
No
The device description clearly outlines a reagent set and its use with a turbidimetric clinical analyzer, which are hardware components. The software mentioned is for data reduction and storing calibration curves, but it is part of a larger hardware-based system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of human lipoprotein(a) in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer." This is a classic description of an in vitro diagnostic test performed on a biological sample (serum) outside of the body.
- Device Description: The description details a laboratory procedure involving reagents, samples, and an analyzer to measure a substance in serum. This aligns with the definition of an IVD.
- Anatomical Site: The anatomical site is "human serum," which is a biological specimen used for in vitro testing.
- Performance Studies: The performance studies describe clinical correlation, recovery, and reproducibility using laboratory samples and comparing results to other methods. These are typical studies conducted for IVD devices.
- Predicate Device: The mention of a "Predicate Device" (Strategic Diagnostics Macra Lp(a)) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared device.
The entire description points to a test performed on a biological sample in a laboratory setting to provide diagnostic information, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) 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.
Product codes
DFC
Device Description
The SPQ™ Test System for Lp(a) provides the quantitative determination of human lipoprotein(a) by automated immunoprecipitin analysis. Standards, controls, and samples are pipetted undiluted into sample cups. Microvolumes of these samples and a polymeric enhancer are pipetted into individual cuvettes. Following an initial incubation and measurement of sample blank, undiluted antiserum is added to the cuvettes. The sample and antiserum are mixed in the reaction cuvettes. Reaction temperature is controlled at 37°C. Insoluble antibody complexes form immediately, producing turbidity in the mixture and increasing the amount of light scattered by the solution. The amount of antigen-antibody complex formed, and thus the amount of light scatter, is proportional to the amount of lipoprotein(a) in the initial sample. The solution absorbance is measured after a 10 minute incubation period.
A calibration curve is generated by analyzing a series of calibrators with known concentrations of lipoprotein(a) and using the instrument's data reduction capability or manually plotting the change in absorbance versus lipoprotein(a) concentration. Concentrations of lipoprotein(a) within the controls and samples are interpolated from the calibration curve.
The test is designed for use on instruments capable of immunoprecipitin analysis, as the Cobas FARA II. The instruments measure the amount of light scattering in the reaction cuvettes due to the formation of insoluble antigen-antibody complexes. The systems are capable of storing a calibration curve. This assay is not designed for manual use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
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
Clinical Correlation: A clinical study was conducted with the SPQ Test System to assess whether the assay could detect a difference in Lo(a) levels between a normal population with known cardiac risk factors and a population with known atherosclerotic heart disease. The median Lp(a) level for the normal male population was 11.6 mg/dL, while the median level for the diseased male population was 26.3 mg/dL. The populations were statistically significantly different.
The assay was compared to the Northwest Lipid Research Laboratory reference method and to the Strategic Diagnostics Macra assay. The correlation coefficient to the NWLRL assay was 0.962 (equivalent to the correlation of the Macra assay to the NWLRL method) and the correlation to the Macra assay was 0.961.
Recovery: A study was performed to evaluate the quantitative recovery of different Lp(a) polymorphs which spanned the molecular weight range from 419 to 796 kD. A model of dilution parallelism was used to test whether the different polymorphs were recovered equivalently. Statistical analysis of the data obtained from this study showed that no departure from parallelism was observed.
Reproducibility: Reproducibility studies were performed at 3 sites using one lot of SPQ reagents. Assay reproducibility was determined by testing 6 samples that spanned the range of the assay as well as the 2 control samples. Samples were tested in duplicate once a day for 7 days over a 2 week period. The results are summarized below.
Key Metrics
| Sample | Mean
mg/dL | Within
Run %CV | Total
%CV |
|---|---|---|---|
| Level 1 Control | 22.3 | 4.0 | 5.4 |
| Level 2 Control | 52.0 | 2.7 | 4.9 |
| RP 1 | 9.9 | 9.4 | 13.9 |
| RP 2 | 21.9 | 3.6 | 7.7 |
| RP 3 | 45.2 | 3.1 | 6.1 |
| RP 4 | 58.4 | 5.3 | 8.6 |
| RP 5 | 71.9 | 2.6 | 4.9 |
| RP 6 | 85.5 | 2.0 | 3.6 |
| N | 42 | | |
Predicate Device(s)
Strategic Diagnostics Macra Lp(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
MAR-31-99 WED 04:43 PM
AMERICANSTANDARDDIASORIN
31-99 WED 04:43
4/2/99
FAX NO. +301 497 1126 P. 04
K982708
510(K) SUMMARY
SUBMITTED BY:
Judith J. Smith DiaSorin, Inc. 9175 Guilford Rd. Suite 100 Columbia, MD 21046
NAME OF DEVICES: Trade Name:
SPQ Test System Antibody Reagent Set for Lp(a)
Immunoprecipitin assay for quantitative
Common Names/Descriptions:
Classification Names:
Strategic Diagnostics Macra Lp(a)
determination of Lp(a) levels
Lipoprotein a (Lp(a)) test
PREDICATE DEVICES:
DEVICE DESCRIPTION:
INTENDED USE: The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) 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.
KIT DESCRIPTION: The SPQ™ Test System for Lp(a) provides the quantitative determination of human lipoprotein(a) by automated immunoprecipitin analysis. Standards, controls, and samples are pipetted undiluted into sample cups. Microvolumes of these samples and a polymeric enhancer are pipetted into individual cuvettes. Following an initial incubation and measurement of sample blank, undiluted antiserum is added to the cuvettes. The sample and antiserum are mixed in the reaction cuvettes. Reaction temperature is controlled at 37°C. Insoluble antibody complexes form immediately, producing turbidity in the mixture and increasing the amount of light scattered by the solution. The amount of antigen-antibody complex formed, and thus the amount of light scatter, is proportional to the amount of lipoprotein(a) in the initial sample. The solution absorbance is measured after a 10 minute incubation period.
A calibration curve is generated by analyzing a series of calibrators with known concentrations of lipoprotein(a) and using the instrument's data reduction capability or manually plotting the change in absorbance versus lipoprotein(a) concentration. Concentrations of lipoprotein(a) within the controls and samples are interpolated from the calibration curve.
The test is designed for use on instruments capable of immunoprecipitin analysis, as the Cobas FARA II. The instruments measure the amount of light scattering in the reaction cuvettes due to the formation of insoluble antigen-antibody complexes. The systems are capable of storing a calibration curve. This assay is not designed for manual use.
1
PERFORMANCE DATA: All performance data were collected using the Cobas FARA II. Clinical Correlation: A clinical study was conducted with the SPQ Test System to assess whether the assay could detect a difference in Lo(a) levels between a normal population with known cardiac risk factors and a population with known atherosclerotic heart disease. The median Lp(a) level for the normal male population was 11.6 mg/dL, while the median level for the diseased male population was 26.3 mg/dL. The populations were statistically significantly different.
The assay was compared to the Northwest Lipid Research Laboratory reference method and to the Strategic Diagnostics Macra assay. The correlation coefficient to the NWLRL assay was 0.962 (equivalent to the correlation of the Macra assay to the NWLRL method) and the correlation to the Macra assay was 0.961.
Recovery: A study was performed to evaluate the quantitative recovery of different Lp(a) polymorphs which spanned the molecular weight range from 419 to 796 kD. A model of dilution parallelism was used to test whether the different polymorphs were recovered equivalently. Statistical analysis of the data obtained from this study showed that no departure from parallelism was observed.
Reproducibility: Reproducibility studies were performed at 3 sites using one lot of SPQ reagents. Assay reproducibility was determined by testing 6 samples that spanned the range of the assay as well as the 2 control samples. Samples were tested in duplicate once a day for 7 days over a 2 week period. The results are summarized below.
| Sample | Mean
mg/dL | Within
Run %CV | Total
%CV |
|-----------------|---------------|-------------------|--------------|
| Level 1 Control | 22.3 | 4.0 | 5.4 |
| Level 2 Control | 52.0 | 2.7 | 4.9 |
| RP 1 | 9.9 | 9.4 | 13.9 |
| RP 2 | 21.9 | 3.6 | 7.7 |
| RP 3 | 45.2 | 3.1 | 6.1 |
| RP 4 | 58.4 | 5.3 | 8.6 |
| RP 5 | 71.9 | 2.6 | 4.9 |
| RP 6 | 85.5 | 2.0 | 3.6 |
| N | 42 | | |
REPRODUCIBILITY RESULTS FOR SPQ LP(A) ASSAY - COMBINED SITES
2
Public Health Service
APR 2 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Judith J. Smith DiaSorin, Inc. 9175 Guilford Road, Suite 100 Ouarry Park Place Columbia, Maryland 21046 Re: K982708 Trade Name: SPO Test System Antibody Reagent Set for Lp(a) Regulatory Class: II Product Code: DFC
II I Dated: March 4, 1999 Received: March 5, 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.
IIS
JJX
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.
Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
3
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
Page 1 of 1
510(k) NUMBER: K982708
DEVICE NAME: Antibody Reagent Set for Lp(a) SPQ™ Test System
INDICATIONS FOR USE: The SPQTM Antibody Reagent Set for Lp(a) is designed for the quantitative determination of human lipoprotein(a) in human serum by immunoprecipitin analysis using a turbidimetric clinical analyzer. The measurment 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.
K982708 Jun Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982708
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)