(33 days)
No
The summary describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is described as an assayed quality control material used to monitor the precision of laboratory testing procedures, not to treat a disease or condition.
No
The device is described as an "assayed quality control material" intended to "monitor the precision of laboratory testing procedures." This indicates it is used for quality control of testing equipment, not for diagnosing a patient's medical condition. It does not provide information about a disease, condition, or state of health.
No
The device description clearly states it is a "liquid product prepared from human whole blood," indicating it is a physical material, not software.
Yes, 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 laboratory testing procedures for the analytes listed in the package insert." This is a classic function of an IVD, specifically a quality control material used in laboratory testing.
- Device Description: It's a "liquid product prepared from human whole blood containing preservatives and stabilizers." This describes a biological material designed to be used in laboratory tests.
- Intended User / Care Setting: It's intended for "laboratory testing procedures," which is the environment where IVDs are used.
While it doesn't involve image processing, AI, or specific patient demographics, its purpose and composition clearly align with the definition of an In Vitro Diagnostic device used in a laboratory setting. The mention of a predicate device (K862186; Lyphochek Diabetes Control) further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
N/A
Intended Use / Indications for Use
"Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert."
Product codes
GGM
Device Description
"This is a liquid product prepared from human whole blood containing preservatives and stabilizers."
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
"laboratory testing procedures"
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 this Control. Product claims are as follows:
• . Open vial Stability: 14 days at 2 to 8°C.
• . Shelf Life: 3 years at -10 to 70°C or 6 months when stored tightly capped at 2 to 8°C.
All supporting data is retained on file at Bio-Rad Laboratories."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Bio-Rad Laboratories Liquichek Diabetes Control Summary of Safety and Effectiveness
NOV - 9 2005
1.0 Submitter
NOV - 9 2005
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
September 16, 2005
2.0 Device Identification
| Product Name: | Liquichek Diabetes Control |
|---|---|
| Common Name: | Hematology and Pathology Devices |
| Hematology quality control mixture | |
| Classifications: | Class II |
| Classifications: | Class II |
|---|---|
| Product Code: | GGM |
| Regulation Number: | 21 CFR 864.8625 |
3.0 Device to Which Substantial Equivalence is Claimed
Lyphochek Diabetes Control Bio-Rad Laboratories Irvine, California 92618
510 (k) Number: K862186
4.0 Description of Device
This is a liquid product prepared from human whole blood containing preservatives and stabilizers.
5.0 Intended Use
Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
1
Comparison of the new device with the Predicate Device 6.0
Liguichek Diabetes Control claims substantial equivalence to the Lyphochek Diabetes Control currently in commercial distribution (K862186). Both of these are whole blood based controls .
| Characteristics | Bio-Rad Laboratories
Liquichek™ Diabetes Control
(New Device) | Bio-Rad Laboratories
Lyphochek Diabetes Control
(Predicate Device K862186) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Diabetes Control is intended for use as an assayed
quality control material to monitor the precision of laboratory
testing procedures for the analytes listed in the package insert. | Lyphochek Diabetes Control is intended for use as an assayed
quality control material to monitor the precision of laboratory
testing procedures for the analytes listed in the package insert. |
| Matrix | Human Whole Blood based | Human Whole Blood based |
| Preservatives | Contains preservatives | Contains preservatives |
| Differences | | |
| Form | Liquid | Lyophilized |
| Storage (Unopened) | -10C to -70°C Until expiration date or
2°C to 8°C for 6 months | 2°C to 8°C
Until expiration date |
| Open Vial Claim | 14 days at 2°C to 8 °C | 7 days at 2 to 8 °C |
| Analytes | Contains:
Hemoglobin A1C Total Hemoglobin Does not contain: Hemoglobin A1 Hemoglobin F Total Glycated Hemoglobin | Contains:
Hemoglobin A1C Hemoglobin A1 Hemoglobin F Total Glycated Hemoglobin Does not Contain: Total Hemoglobin |
Table 1. Similarities and Differences between new and predicate device.
7.0 Statement of Supporting Data
Stability studies have been performed to determine the open vial stability and shelf life for this Control. Product claims are as follows:
- . Open vial Stability: 14 days at 2 to 8°C.
- . Shelf Life: 3 years at -10 to 70℃ or 6 months when stored tightly capped at 2 to 8°C.
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 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 top half of the circle. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 9 2005
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K052838
Trade/Device Name: Liquichek Diabetes Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: GGM Dated: October 5, 2005 Received: October 7, 2005
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).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours.
Alberto Gutz
Alberto Gutierrez, Ph.D. 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 Diabetes Control
Indications For Use:
Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Prescription Use X (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)
Carol Benson
Division Sign-Off
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
51001 K052838