(133 days)
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No
The device description and performance studies describe a standard in vitro diagnostic assay based on turbidimetry, with no mention of AI or ML.
No.
Explanation: This device is an in vitro diagnostic assay used for quantitative determination of apolipoprotein A1, which aids in diagnosis and treatment, but it does not directly administer therapy to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the "Measurement of A lipoproteins... is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia." This indicates the device provides information for diagnostic purposes.
No
The device description clearly states it is an "in vitro diagnostic assay" that uses antibodies and measures light scattering (turbidity) to determine the concentration of apolipoprotein A1. This indicates a physical reagent and measurement system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. This indicates it's used to analyze biological samples from the human body.
- Device Description: The "Device Description" further clarifies that it's an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living organism.
- Purpose: The assay is used in the diagnosis and treatment of various conditions related to apolipoprotein A1 levels. This is a key characteristic of IVDs, which are used to provide information for diagnostic or treatment decisions.
- Method: The description of the method (measuring turbidity caused by immune complexes) is consistent with laboratory-based diagnostic tests.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.
Product codes
DER
Device Description
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
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
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Summary of Performance Studies
Comparative performance studies were conducted using the AEROSET™ System. The Apolipoprotein A1 assay method comparison yielded acceptable correlation with the K-ASSAY Apo A1 on the Hitachi 717 Analyzer. The correlation coefficient = 0.9919, slope = 0.976, and Y-intercept = 6.236 mg/dL. Precision studies were conducted using the Apolipoprotein A1 assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 2.1%. The Apolipoprotein A1 assay range is up to 464 mg/dL. The limit of quantitation (sensitivity) for the Apolipoprotein A1 assay is 0.525 mg/dL. These data demonstrate that the performance of the Apolipoprotein A1 assay is substantially equivalent to the performance of the K-ASSAY Apo A1 on the Hitachi 717 Analyzer.
Key Metrics
correlation coefficient = 0.9919, slope = 0.976, and Y-intercept = 6.236 mg/dL. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 2.1%. The Apolipoprotein A1 assay range is up to 464 mg/dL. The limit of quantitation (sensitivity) for the Apolipoprotein A1 assay is 0.525 mg/dL.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5580
Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).
0
KG8 3289
JAN 2 9 1399
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Section II
510(k) Summary
Apolipoprotein A1 510(k)
September 17. 1998
ApoA_Vi.lwp
Section II
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510(k) Summary
Submitter's Name/Address Contact Person Abbott Laboratories Linda Morris Senior Regulatory Specialist MS 1-8 1920 Hurd Drive Irving, Texas 75038 Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
| Date of Preparation of this Summary: | Month, 1998 |
|---|---|
| Device Trade or Proprietary Name: | ApoA |
| Device Common/Usual Name or Classification Name: | Apolipoprotein A1 |
| Classification Number/Class: | Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _ (4832 89
Test Description:
Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 804 nm, is directly proportional to the concentration of apolipoprotein A1 in the sample.
Substantial Equivalence:
The Apolipoprotein A1 assay is substantially equivalent to the K-ASSAY® Apo A1 (K964292) on the Hitachi® 717 Analyzer.
Apolipoprotein A1 510(k) September 17, 1998 ApoA_VI.Iwp
Section II Page 1
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Both assays yield similar Performance Characteristics.
Similarities:
- . Both assays are in vitro immunoassay methods.
- Both assays can be used for the quantitative determination of apolipoprotein A1. .
- . Both assays vield similar clinical results.
- . Both assays are based on the formation of immune complexes.
Differences:
- There is a difference between the assay range. .
Intended Use:
The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Apolipoprotein A1 assay method comparison yielded acceptable correlation with the K-ASSAY Apo A1 on the Hitachi 717 Analyzer. The correlation coefficient = 0.9919, slope = 0.976, and Y-intercept = 6.236 mg/dL. Precision studies were conducted using the Apolipoprotein A1 assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 401 is 2.1% and Level 2/Panel 402 is 2.1%. The Apolipoprotein A1 assay range is up to 464 mg/dL. The limit of quantitation (sensitivity) for the Apolipoprotein A1 assay is 0.525 mg/dL. These data demonstrate that the performance of the Apolipoprotein A1 assay is substantially equivalent to the performance of the K-ASSAY Apo A1 on the Hitachi 717 Analyzer.
Apolipoprotein A1 510(k) September 17, 1998 ADOA VI.Iwn
Section II Page 2
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3
Conclusion:
The Apolipoprotein A1 assay is substantially equivalent to the K-ASSAY Apo A1 on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
:"
,
Apolipoprotein A1 510(k) September 17. 1998 ApoA_V1.lwp
Section II Page 3
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Public Health Service
Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.
JAN 29 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Regulatory Specialist Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Re: K983289 Trade Name: AEROSET Apolipoprotein A1 Regulatory Class: II Product Code: DER Dated: December 3, 1998 Received: December 4, 1998
Dear Ms. Morris:
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 (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
6
, "
510(k) Number (if known): ---
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Apolipoprotein A1 assay is used for the quantitation of apolipoprotein A1 in human serum or plasma. Measurement of A lipoproteins, the major proteins found in HDL (high density lipoprotein), is used in the diagnosis and treatment of premature coronary artery disease, hyper-a-lipoproteinemia, and hypo-α-lipoproteinemia.
(Division Sign-Off) ( Division of Clinical Laboratory Levices
$10(k) Number_ _ K a Clinical Laboratory Levices
$10(k) Number_ _ K a Clinical Laboratory Levices
$10(k) Number_ _ K a Clinical Labo 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use Prescription Use V OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
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