(276 days)
Not Found
Not Found
No
The provided text describes a laboratory test kit using an immunoturbidimetric assay for quantitative determination of apoprotein A-l. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is a test kit for quantitative determination of a protein in human serum, useful in the diagnosis of atherosclerosis, but it does not treat or cure a disease.
Yes
The device is intended for the "quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay," and its measurement is "useful in the diagnosis of atherosclerosis." This indicates its role in identifying a medical condition.
No
The intended use describes a test kit for quantitative determination of human apoprotein A-l in human serum using an immunoturbidimetric assay. This clearly indicates a physical test kit and laboratory process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit is for the "quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay." This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to provide information for diagnosis.
- Diagnosis: The intended use also explicitly states that the measurement is "useful in the diagnosis of atherosclerosis." This directly links the test results to a diagnostic purpose.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The N-Assay TIA Apoprotein A-1 Test Kit is intended to be used for the quantitative determination of human apoprotein A-1 in human serum by immunoturbidimetric assay. The measurement of apoprotein A-1 is useful in the diagnosis of atherosclerosis.
Product codes
DER
Device Description
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/10 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wavy lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CRESTAT DIAGNOSTICS, INC. c/o Ms. Mary Rees Official Correspondent KAMIYA TECHNOLOGY SERVICES 374 Goodhill Road Weston, CT 06883
AUG - 1 1997
K964292/S002 Re: Trade Name: N-Assay® TIA Apolipoprotein A-1 Test Kit Requlatory Class: II Product Code: DER Dated: May 04, 1997 Received: May 09, 1997
Dear Ms. Rees:
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 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 requirement, 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 Requlations.
1
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 www 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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
2
| Page | of | 1 |
|---|---|---|
| ------ | ---- | --- |
10(k) Number lil known):_
N-Assay TIA Apoprotein A-l cvice Name:_
к 964292
dications I or Use:
The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement
in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow.
of apoprotein A-l is useful in the diagnosis of atherosclerosis.
Peter E. Maker
(Division Sign-Off) Division of Clinical La 510(k) Number
PLEASE OO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF EDED)
Concurrence of CORH, Office of Device Evaluation (ODE) 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 ()に Doce The Counter Use . _ _ _ _ _ 1 CFR 801 (Ontional Formar 1-2-96)
海房利 新疆菲律 T