(12 days)
Not Found
No
The summary describes a quality control serum for laboratory procedures and does not mention any AI or ML components.
No.
The device is described as an "assayed quality control serum to monitor the precision of an individual laboratory's specific cardiac marker procedures", indicating it is used for quality control of diagnostic tests, not for directly treating a condition in a patient.
No
Explanation: This device is a quality control material used to monitor the precision of cardiac marker procedures, not to diagnose a patient's condition.
No
The device description clearly states it is a liquid control serum, which is a physical substance, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of an individual laboratory's specific cardiac marker procedures." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It's a "quality control serum" prepared from biological materials (human serum). Quality control materials are a key component of IVD testing to ensure accuracy and reliability.
- Predicate Device: The mention of a predicate device (K961828; Liquichek Cardiac Markers Control) strongly suggests it's a regulated medical device, and quality control materials for diagnostic tests fall under the IVD category.
The other sections being "Not Found" or irrelevant to the core definition of an IVD (like image processing, AI, anatomical site, etc.) do not negate its classification as an IVD based on its intended use and description.
N/A
Intended Use / 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 marker procedures.
Product codes (comma separated list FDA assigned to the subject device)
JJT
Device Description
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.
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.
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
§ 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.
0
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.
1
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 Liquichek
Cardiac Markers Control | Bio-Rad Liquichek
Cardiac Markers Control LT |
|--------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended
Use | To monitor the precision of a
laboratories specific cardiac
markers procedures. | To monitor the precision of a
laboratories 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 is targeted at
higher levels | Troponin I is targeted at
lower levels |
2
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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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 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