(12 days)
Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.
Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.
The provided document is a 510(k) summary for the Bio-Rad Liquichek Cardiac Markers Control LT. It is a submission to the FDA for a quality control material used in laboratories to monitor cardiac marker procedures. The document establishes substantial equivalence to a previously marketed device (Liquichek Cardiac Markers Control K961828) rather than detailing a study proving performance against acceptance criteria for a new device.
Therefore, many of the requested details about acceptance criteria, study performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or available within this type of regulatory submission for a quality control material.
However, I can extract the relevant information based on the nature of this submission:
1. Table of Acceptance Criteria and Reported Device Performance:
For a quality control material like this, the "acceptance criteria" and "reported device performance" are typically related to demonstrating that the new device has "substantially equivalent" characteristics to a predicate device. The document explicitly provides a comparison table against the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K961828) | Reported Device Performance (Liquichek Cardiac Markers Control LT) |
|---|---|---|
| Intended Use | To monitor the precision of a laboratory's specific cardiac markers procedures. | To monitor the precision of a laboratory's specific cardiac markers procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Analytes | Total CK, CK-MB Isoenzyme, LD-1 Isoenzyme, Myoglobin, Troponin-I, Troponin T | Total CK, CK-MB Isoenzyme, LD-1 Isoenzyme, Myoglobin, Troponin-I, Troponin T |
| Open Vial Claim | 20 Days at 2-8°C for all analytes; except Troponin T which is stable for 10 Days at 2-8°C | 20 Days at 2-8°C for all analytes; except Troponin T which is stable for 10 Days at 2-8°C |
| Differences (Troponin I Target Levels) | Troponin I is targeted at higher levels | Troponin I is targeted at lower levels |
Rationale for "Acceptance Criteria" here: In the context of a 510(k) for a quality control material, the acceptance criteria for a new device are primarily its ability to match the essential characteristics and performance of a legally marketed predicate device, demonstrating that it is "substantially equivalent." The key difference noted (Troponin I targeted at lower levels) is considered acceptable as it still serves the intended purpose of a control, just at a different target level. The FDA's approval letter confirms their determination of substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. For a quality control material intended to monitor laboratory precision, testing would typically involve evaluating the stability, homogeneity, and analyte values across multiple lots and over time, compared to established reference methods or predicate controls. The document does not provide details on the specific sample sizes used for such internal characterization studies.
- Data Provenance: Not specified in terms of country of origin. The submission is made by Bio-Rad Laboratories, located in Irvine, California, USA. The studies would have been conducted internally by Bio-Rad. It is an internal characterization study for the control material itself, rather than a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. For a quality control material, the "ground truth" (i.e., the assigned values for analytes) is established through rigorous analytical testing using reference methods and comprehensive characterization studies performed by qualified laboratory personnel at the manufacturer's facility, not by external experts or adjudication panels in the way a diagnostic algorithm might be evaluated.
- Qualifications of Experts: Not applicable in the context of an adjudication panel. The analyses would be performed by qualified laboratory scientists and technicians.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. Adjudication methods like 2+1 are used in clinical studies where expert consensus is needed to establish a "ground truth" for diagnostic outcomes. For a quality control material, the "true" values are determined by analytical methods, not by expert consensus.
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:
- MRMC Study: No. This is a quality control material, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study was performed, and the concept of "human readers improving with AI" does not apply.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical quality control material, not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For a quality control material, the "ground truth" refers to the target or assigned values for each analyte within the control. This is established through analytical testing using validated reference methods and internal laboratory characterization studies, including repeat measurements on multiple instruments, potentially against reference materials, and stability studies. It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set. The values and characteristics of the control are determined through laboratory characterization, not by training an AI model.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device type.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is a black rectangle with rounded corners, and the words "BIO-RAD" are written in white, bold letters. The letters are sans-serif and are evenly spaced. The logo is simple and recognizable.
Blo-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
808560
FEB 2 5 1998
510(k) Summary
- Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (714)598-1285 Fax (714)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation February 12, 1998
Device (Trade & Common Name) Liquichek Cardiac Markers Control LT
Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Liquichek Cardiac Markers Control Bio-Rad Laboratories, Anaheim, CA K961828
Statement of Intended Use
Liquichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in white, bold, sans-serif font. The text is set against a black, rounded rectangle.
Blo-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (714) 598-1200
Description of the Device
Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.
Statement of How Technological Characteristics Compare to Substantial Equilavence Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek Cardiac Markers Control LT and the devices to which substantial equivalence is claimed.
| Bio-Rad LiquichekCardiac Markers Control | Bio-Rad LiquichekCardiac Markers Control LT | |
|---|---|---|
| IntendedUse | To monitor the precision of alaboratories specific cardiacmarkers procedures. | To monitor the precision of alaboratories specific cardiacmarkers procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Analytes | Total CK, CK-MBIsoenzyme, LD-1Isoenzyme, Myoglobin,Troponin-I, Troponin T | Total CK, CK-MBIsoenzyme, LD-1Isoenzyme, Myoglobin,Troponin-I, Troponin T |
| Open VialClaim | 20 Days at 2-8°C for allanalytes; except Troponin Twhich is stable for10 Days at 2-8°C | 20 Days at 2-8°C for allanalytes; except Troponin Twhich is stable for10 Days at 2-8°C |
| Differences | Troponin I is targeted athigher levels | Troponin I is targeted atlower levels |
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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 5 1998
Elizabeth Platt . Staff Regulatory Affairs Representative Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017
Re : K980556 Liquichek Cardiac Markers Control LT Requlatory Class: I Product Code: JJT February 12, 1998 Dated: Received: February 13, 1998
Dear Ms. Platt:
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 aqainst 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 In addition, FDA may publish further announcements action. 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 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 deberined in your cial 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/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 1 of 1
510(k) Number: K980556
Liquichek Cardiac Markers Control LT Device Name:
Indications for Use:
Liquichek Cardiac Markers Control LT is intended for use as an_assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac markers procedures.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR Over-The Counter Use
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K980556
§ 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.