(35 days)
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.
This is a lyophilized product prepared from human whole blood containing preservatives and stabilizers.
The Bio-Rad Laboratories Lyphochek Diabetes Control is a quality control material, not a diagnostic device that measures patient outcomes or makes clinical decisions. Therefore, the typical acceptance criteria and study designs involving diagnostic performance metrics like sensitivity, specificity, or reader studies are not applicable.
Instead, the "acceptance criteria" for this type of device revolve around its stability and its ability to consistently monitor the precision of laboratory testing procedures for specific analytes over time. The "study" that proves the device meets these criteria is a stability study.
Here's a breakdown of the information requested, adapted for a quality control material:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance/Evidence |
|---|---|---|
| Open Vial Stability | The control material must maintain its stated analyte values and demonstrate acceptable precision for 7 days when stored at 2 to 8°C after opening. | "Open vial Stability: 7 days at 2 to 8°C." The device maintained its intended performance characteristics for 7 days after opening, under recommended storage conditions, allowing laboratories to reliably monitor assay precision during this period. The specific details of how "acceptable precision" was defined and measured are not provided in this summary but would be part of the full stability study. |
| Shelf Life | The control material must maintain its stated analyte values and demonstrate acceptable precision for 3 years when stored unopened at 2 to 8°C. | "Shelf Life: 3 Years at 2 to 8°C." The device maintained its intended performance characteristics for 3 years when stored unopened, under recommended storage conditions, ensuring its usability for the stated period. The specific details of how "acceptable precision" was defined and measured are not provided in this summary but would be part of the full stability study. |
| Claimed Analytes | The device must reliably monitor the precision of laboratory testing procedures for the claimed analytes, specifically including Total Hemoglobin (which is the new claim). | The device's formulation is "exactly the same" as the predicate, which already had claims for Hemoglobin A1C, Hemoglobin A1, Hemoglobin F, and Total Glycated Hemoglobin. The new device adds a claim for Total Hemoglobin. The stability study implicitly validates the stability for this new analyte alongside the others. While specific data isn't shown, the FDA found it substantially equivalent based on the provided data. |
Important Note: The provided summary does not detail the specific metrics used to define "acceptable precision" for the analytes (e.g., specific coefficients of variation or acceptable biases) or the raw data from the stability studies. These would be found in the full submission to the FDA.
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable in the traditional sense for a quality control material's stability study.
- "Test Set": In a stability study for a QC material, the "test set" would be various lots of the manufactured control material that are subjected to different storage conditions and timepoints. The number of vials/aliquots tested at each time point would constitute the "sample size" for that specific test run. The document does not specify the number of lots or aliquots used in the stability studies.
- Data Provenance: Not specified, but generally, such studies are conducted internally by the manufacturer (Bio-Rad Laboratories in Irvine, California, USA) according to established quality system procedures and regulatory guidelines. It would be prospective, as the stability of newly manufactured batches is monitored over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. For a quality control material, the "ground truth" for its analyte values is established through reference methods or highly accurate assays performed in a controlled laboratory setting by qualified analytical chemists or laboratory scientists during the manufacturing and characterization process. It's not based on expert consensus for interpretation like in diagnostic imaging.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations of diagnostic data. For a stability study, the data points are quantitative measurements of analyte concentrations, and any discrepancies would be resolved through re-testing, statistical analysis of replicates, or investigation of assay performance, not expert adjudication of qualitative interpretations.
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
This is not applicable. This type of study is relevant for diagnostic devices, particularly those involving human interpretation, often assisted by AI. The Lyphochek Diabetes Control is a reagent used to monitor the precision of laboratory instruments, not a device that humans directly interpret for diagnostic purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This device is a physical control material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the analyte values (e.g., the target values for Hemoglobin A1C, Total Hemoglobin, etc.) in the Lyphochek Diabetes Control would be established through a combination of:
- Reference Methods: Highly accurate and precise analytical methods (e.g., HPLC, mass spectrometry) that are traceable to international reference materials.
- Certified Reference Materials (CRMs): The control material would be assayed against CRMs to assign accurate target values for the analytes.
- Internal Characterization Studies: Extensive testing during manufacturing to determine the mean and acceptable range for each analyte in each lot.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a quality control material stability study. The control material's characteristics are determined through analytical testing, not machine learning or algorithmic training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set. The "ground truth" for the control material's characteristics (analyte values and stability) is established through rigorous analytical testing using reference methods and comprehensive stability studies, as described in point 7.
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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
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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 LaboratoriesLyphochek Diabetes Control(New Device) | Bio-Rad LaboratoriesLyphochek Diabetes Control(Predicate Device K862186) |
|---|---|---|
| Similarities | ||
| Intended Use | Lyphochek Diabetes Control is intended for use as an assayedquality control material to monitor the precision of laboratorytesting procedures for the analytes listed in the package insert. | Lyphochek Diabetes Control is intended for use as an assayedquality control material to monitor the precision of laboratorytesting 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°CUntil expiration date | 2°C to 8°CUntil 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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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) 276-0490. 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
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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
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Office of In Vitro Diagnostic Device Evaluation and Sa
§ 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.