(71 days)
The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.
Not Found
Due to the limited information in the provided document, I cannot fulfill all parts of your request. This document is a 510(k) clearance letter for a medical device (Triglycerides Reagent) and does not contain detailed study information regarding acceptance criteria or performance data.
Here's what I can extract and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document. The FDA letter confirms the device is "substantially equivalent" to predicate devices, implying it meets general performance expectations for this type of in-vitro diagnostic. Specific numerical acceptance criteria (e.g., accuracy, precision limits) are not provided.
- Reported Device Performance: Not included in the document. The letter acknowledges that the manufacturer provided information to support substantial equivalence, but the actual performance data is not detailed here.
2. Sample size used for the test set and the data provenance:
- Sample size: Not mentioned in this document.
- Data provenance: Not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned in this document.
4. Adjudication method for the test set:
- Not mentioned in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This device is a Triglycerides Reagent, an in-vitro diagnostic (IVD) for quantitative determination of serum triglycerides. It is not an AI-assisted diagnostic imaging device or a device involving human "readers" in the context of imaging interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question also appears to be framed from the perspective of an AI/algorithm-based diagnostic device. As a chemical reagent, the concept of "standalone algorithm performance" doesn't directly apply. The performance of the reagent would be assessed through analytical and clinical validation studies, but not in the sense of a standalone algorithm for image analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For an in-vitro diagnostic like a triglycerides reagent, the "ground truth" would typically be established through:
- Reference methods: Comparing the device's results to a more established, highly accurate reference method for triglyceride measurement.
- Clinical correlation: Showing that the triglyceride levels determined by the device correlate with clinical conditions (e.g., risk of coronary artery disease, pancreatitis) or patient outcomes as expected.
- Known concentration controls: Testing the device with samples of known triglyceride concentrations.
- This document does not specify which type of ground truth was used for the submission.
8. The sample size for the training set:
- Not mentioned in this document. (Training sets are more relevant for machine learning algorithms, which this device is not).
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device requiring a "training set" in that context.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 20 1997
Cynthia Shugart President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821
Re: K971324 Triglycerides, TG, or TRIG Reagent Regulatory Class: I Product Code: CDT Dated: April 8, 1997 Received: April 10, 1997
Dear Ms. Shugart:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (CMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (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/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Page_3__of_35_
510(k) Number (if known):___
Device Name:_Triglycerides Reagent
Indications For Use:
The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s.
Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K971324 |
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.(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.