(34 days)
Not Found
No
The device is a quality control serum, which is a chemical reagent used to monitor the accuracy of laboratory tests. There is no indication of any software or algorithmic component, let alone AI/ML.
No.
This device is described as an assayed quality control serum used to monitor the precision of laboratory testing procedures, not to treat a medical condition.
No
This device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," not to diagnose an illness or condition in a patient. It is used to ensure the accuracy of diagnostic tests.
No
The device is a liquid quality control serum, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." This clearly indicates it's used in vitro (outside the body) to assess the performance of laboratory tests.
- Device Description: The description mentions it's prepared from human serum and used in liquid form, consistent with a laboratory reagent or control.
- Intended User / Care Setting: It's intended for use in a "laboratory," which is the typical setting for IVD testing.
Quality control materials like this are a crucial part of ensuring the accuracy and reliability of IVD tests.
N/A
Intended Use / Indications for Use
For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJT, JJY
Device Description
Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form.
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)
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Control LT. Product claims are as follows:
- Open vial: All analytes will be stable for 10 days with the following exceptions: NT-proBNP will be 2.1 stable for 5 days. .
- 2.2 Shelf Life: 2 years at -20°C or colder
- 2.3 Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
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
MAR 1 0 2004
Summary of Safety and Effectiveness Liquichek™ Cardiac Markers Control LT
KD40277
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1557 Fax:
Contact Person
Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
February 4, 2004
2.0 Device Identification
| Product Trade Name: | Liquichek Cardiac Markers Control LT |
|---|---|
| Common Name: | Enzyme Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJT |
| Regulation Number: | CFR 862.1660 |
3.0 Device to Which Substantial Equivalence is Claimed
Bio-Rad Laboratories Irvine, California
Liquichek™ Cardiac Markers Control LT Docket Number: K021498
4.0 Description of Device
Liquichek Cardiac Markers Control LT is prepared from human serum with added constituents of human and animal origin, preservatives and stabilizers. The control is provided in liquid form.
5.0 Statement of Intended Use
Liguichek Cardiac Markers Control LT is intended for use as an assayed quality control serum to monitor the precision of laboratory procedures listed in the package insert.
6.0 Preservatives:
The Liquichek Cardiac Markers Control LT does not contain sodium azide as a preservative. It contains a broad-spectrum anti-microbial cocktail as a preservative where the concentration of any one ingredient is less than 0.1%. At this low level, these ingredients are not expected to cause a health hazard to the user. And thus, domestic and international regulations do not require this type of information on the vial or box label.
1
Comparison of the new device with the Predicate Device 7.0
Liquichek Cardiac Markers Control LT claims substantial equivalence to the Liquiche distibution Liquichek Gardiac Markers Control Cardiac Markers Control currently in commercial distribution. Markers Control LT and Elquicher Corticity of Claimston Court (Level 1, 2, 3 and Low The Tew Liquicher Octular Manere Outlier of the effect is a tri-level product and does not contain NT-proBNP.
| Characteristics | Bio-Rad
Liquichek™ Cardiac Markers Control LT
(New Device) | Bio-Rad
Liquichek™ Cardiac Markers Control LT
(Predicate Device K021498) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Cardiac Markers Control LT is intended for use as an
assayed quality control serum to monitor the precision of laboratory
testing procedures listed in the package insert. | Liquichek Cardiac Markers Control LT is intended
for use as an assayed quality control serum to
monitor the precision of laboratory testing
procedures listed in the package insert. |
| Form | Liquid | Liquid |
| Matrix | Human serum based | Human serum based |
| Storage
(Unopened) | -20°C or colder
Until expiration date | -20°C or colder
Until expiration date |
| Differences | | |
| Number of Levels | Levels 1, 2, 3 and Low Level | Levels 1, 2 and 3 (does not contain Low Level) |
| Open Vial Claim
At 2-8°C | All analytes will be stable for 10 days with the following exceptions:
NT-proBNP will be stable for 5 days. | Troponin-I, Troponin T and Homocysteine: 10 days.
Myoglobin, CK-MB, and Digitoxin: 20 days |
| Analytes | Contains:
NT-proBNP
CK-MB Isoenzyme
Digitoxin
Homocysteine
Myoglobin
Troponin I
Troponin T | Contains: Troponin-I, Troponin T, Myoglobin,
CK-MB, Homocysteine and Digitoxin
Does not contain: NT-pro BNP |
Table 1. Similarities and Differences between new and predicate device.
2.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Cardiac Markers Control LT. Product claims are as follows:
- Open vial: All analytes will be stable for 10 days with the following exceptions: NT-proBNP will be 2.1 stable for 5 days. .
- 2.2 Shelf Life: 2 years at -20°C or colder
- 2.3 Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 0 2004
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
K040277 Re: Trade/Device Name: Liquichek™ Cardiac Markers Control LT ・ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 4, 2004 Received: February 5, 2004
Dear Ms. Zeballos:
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). 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
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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, D.V.M.
Jean M. Cooper, MS, 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
4
Indications for Use
510(k) Number (if known):
Device Name:
Liquichek™ Cardiac Markers Control LT
Indications For Use:
For use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Carl Benson
__
Division Sign-Off
Office of In Vitro Diagnostic on and safety
510(k) K040277
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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)