(42 days)
Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is a human serum based quality control material intended for use as a consistent test sample of known concentration for monitoring assay conditions in immunological determinations. The user can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.
Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is a human serum based quality control material.
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control." This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailing a specific study proving the device meets explicit performance acceptance criteria in the way a diagnostic algorithm or image analysis tool would.
Therefore, the requested information elements related to a study proving device performance (acceptance criteria table, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) are not present in this type of regulatory document.
Here's a breakdown of what can be inferred or stated about the device and the nature of its approval:
1. A table of acceptance criteria and the reported device performance
- Not applicable / Not provided. This document does not specify quantitative acceptance criteria or reported performance metrics for the device itself. The approval is based on a determination of "substantial equivalence" to a legally marketed predicate device. For a quality control material like this, "performance" would relate to its stability, accuracy of assigned values, and consistency in monitoring immunoassays, but these are not quantified here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a clinical performance study with a test set. Substantial equivalence relies on comparing the new device's characteristics and intended use to a predicate device, not necessarily on new clinical performance data in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. No test set or related ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or related adjudication is described.
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
- Not applicable / Not provided. This device is a quality control material, not an AI-powered diagnostic tool, so an MRMC study is irrelevant to its approval.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No clinical ground truth data is involved in the information provided here. For a quality control material, "ground truth" would relate to the accuracy of the assigned values for analytes, which are typically established through reference methods and inter-laboratory studies, but the details are not in this letter.
8. The sample size for the training set
- Not applicable / Not provided. This device is a quality control material, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This device is a quality control material, not an algorithm that requires a training set.
Summary based on the provided document:
The device, "Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control," is a human serum-based quality control material. Its purpose is to provide a consistent test sample with known concentrations to monitor immunoassay conditions, evaluate analytical precision, and assess reagent and instrument performance over time.
The FDA clearance (K993546) was granted based on a determination of substantial equivalence to legally marketed predicate devices. This means the FDA found that the new device is as safe and effective as existing, legally marketed devices. The document explicitly states: "We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent...to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This type of regulatory approval for a quality control material typically involves a comparison of the new device's formulation, manufacturing process, stability, and intended use against an existing predicate, rather than a prospective clinical trial with specific performance acceptance criteria like sensitivity, specificity, or AUC as would be seen for a diagnostic test. Compliance with Good Manufacturing Practice (GMP) requirements (21 CFR Part 820) is also part of the substantial equivalence assumption.
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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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
NOV 30 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Scot Kinghorn Vice President, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058
Re: K993546
Trade Name: Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control Regulatory Class: I Product Code: JJY Dated: October 15, 1999 Received: October 19, 1999
Dear Mr. Kinghorn:
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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLA 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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 of
.510(k) Number (if known): $9935 40
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Tri-Point™ BRAND Liquimmune® Liquid Assayed Immunoassay Control is a human serum based quality control material intended for use as a consistent test sample of known concentration for monitoring assay conditions in immunological determinations. The user can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Matera
1993546
Image /page/2/Picture/9 description: The image shows the words "Prescription Use" in bold font, with a check mark above the word "Use". Below that, the text "(Per 21 CFR 801.109)" is shown. This text likely indicates that the prescription use is in accordance with the Code of Federal Regulations.
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.