(35 days)
Not Found
No
The summary describes a quality control material for laboratory testing, with no mention of AI or ML in its intended use, device description, or performance studies.
No.
The device is described as an "assayed quality control material to monitor the precision of laboratory testing procedures" and is identified as a "lyophilized product prepared from human whole blood." Its intended use is for quality control, not for treating or diagnosing a disease or condition in a patient.
No
The device is described as an "assayed quality control material to monitor the precision of laboratory testing procedures," not to diagnose patients.
No
The device is a lyophilized product prepared from human whole blood, indicating it is a physical material, not software.
Based on the provided information, the 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, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: It's a "lyophilized product prepared from human whole blood." This indicates it's a reagent or material used in a laboratory test.
- Intended User / Care Setting: The intended user is involved in "laboratory testing procedures," which is the typical setting for IVDs.
While it's a quality control material rather than a diagnostic test itself, quality controls are essential components of IVD testing procedures and are considered IVDs by regulatory bodies.
N/A
Intended Use / Indications for Use
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.
Product codes
GGM
Device Description
This is a lyophilized 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
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 this control. Product claims are as follows:
- Open Vial Stability: 7 days at 2 to 8 degrees C.
- Shelf Life: 3 Years at 2 to 8 degrees C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - AllRelevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 Lyphochek Diabetes Control Summary of Safety and Effectiveness
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (949) 598-1557 Fax:
Contact Person
Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Preparation
February 23, 2007
2.0 Device Identification
Product Name: Common Name: Lyphochek Diabetes Control Hematology and Pathology Devices Hematology quality control mixture
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 lyophilized product prepared from human whole blood containing preservatives and stabilizers.
5.0 Intended Use
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.
APR - 2 2007
1
Comparison of the new device with the Predicate Device 6.0
Lyphochek Diabetes Control claims substantial equivalence to the Lyphochek Diabetes Control currently in commercial distribution (K862186). Both of these controls are manufactured with exactly the same formulation. The only difference between the predicate device and the new Lyphochek Diabetes Control is that new product has claims for Total Hemoglobin and the predicate device does not.
| Characteristics | Bio-Rad Laboratories
Lyphochek Diabetes Control
(New Device) | Bio-Rad Laboratories
Lyphochek Diabetes Control
(Predicate Device K862186) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | 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. | 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 |
| Form | Lyophilized | Lyophilized |
| Storage (Unopened) | 2°C to 8°C
Until expiration date | 2°C to 8°C
Until expiration date |
| Open Vial Claim | 7 days at 2 to 8°C | 7 days at 2 to 8°C |
| Differences | | |
| Analytes | Claims:
Hemoglobin A1C Hemoglobin A1 Hemoglobin F Total Glycated Hemoglobin Total Hemoglobin | Claims:
Hemoglobin A1C Hemoglobin A1 Hemoglobin F Total Glycated Hemoglobin Does not Claim 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: 7 days at 2 to 8°C.
- . Shelf Life: 3 Years at 2 to 8°C
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its head turned to the left and its wings forming a curved shape. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bio-Rad Laboratories, QSD c/o Elizabeth Platt Regulatory Affairs Manager 9500 Jeronimo Road Irvine, California 92618
APR - 2 2007
Re: K070546
Trade/Device Name: Lyphochek Diabetes Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology quality control mixture. Regulatory Class: Class II Product Code: GGM Dated: February 23, 2007 Received: February 26, 2007
Dear Ms. Platt:
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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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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., 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:
Lyphochek Diabetes Control
Indications For Use:
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.
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)
i
Carol C Benson
Vision Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Sa