(315 days)
Not Found
Not Found
No
The summary describes a laboratory assay for apolipoproteins using immunoturbidimetric analysis, which is a standard biochemical method and does not mention any AI/ML components.
No
The device is used for diagnostic purposes (quantitative determination of apolipoprotein levels as an aid in risk assessment for coronary artery disease), not for treating or rehabilitating a condition.
Yes
The device is used for the "quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum" and this information is "commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease," which directly supports diagnosis or assessment of a medical condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use describes a laboratory analysis method, which could be performed by a hardware instrument or potentially a software-driven system, but the summary provides no details.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the products are for the "quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis." This involves testing biological samples (human serum) in vitro (outside the body) to obtain diagnostic information.
- Diagnostic Purpose: The intended use also states that the determination of these apolipoproteins is "commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease." This clearly indicates a diagnostic purpose – providing information to help assess a patient's health status and risk.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Intended Use / Indications for Use
These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.
Product codes
MSJ, JIT
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. William F. Walters, Jr. VP-Technical Director Pointe Scientific, Inc. 5449 Research Drive Canton, MI 48188
MAR 2 8 2007
Re: K061377
Trade/Device Name: Apolipoprotein a1 and apolipoprotein b reagents and calibrators Regulation Number: 21 CFR §862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, meets the limitation to exemption in 21 CFR 862.9(c)(4) Product Code: MSJ, JIT Dated: March 15, 2007 Received: March 16, 2007
Dear Mr. Walters:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
1
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K061377
Device Name: Apolipoprotein A1 and Apolipoprotein B reagents and calibrators
Indications For Use:
These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
vision Sign-Off
്ffice of In Vitro Diagnostic Device · valuation and Safety
Page 1 of