(26 days)
K941616, K 895661
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No
The description focuses on standard HPLC technology and statistical analysis of results, with no mention of AI or ML algorithms.
No
The device is intended for the separation and area percent determination of glycohemoglobin (GHb) in whole blood, which is a diagnostic function rather than a therapeutic one.
Yes
The device is intended for the "separation and area percent determination of glycohemoglobin (GHb) in whole blood." It specifically states that "monitoring of total GHb levels has become a routine test for the long-term management of patients with diabetes mellitus," which implies its use in diagnosing and monitoring a medical condition.
No
The device description explicitly states that the "analytical system, consisting of instrument, software and reagent kit, provides an assay". This indicates the device is a system that includes hardware (instrument) and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "separation and area percent determination of glycohemoglobin (GHb) in whole blood". This involves testing a biological sample (whole blood) outside of the body to obtain information about a patient's health status (glycohemoglobin levels).
- Device Description: The description details an "analytical system, consisting of instrument, software and reagent kit" that "provides an assay for the separation and percent determination of glycohemoglobin in whole blood." This clearly describes a system designed for in vitro analysis.
- Purpose: The purpose of measuring glycohemoglobin levels is stated as "monitoring of total GHb levels has become a routine test for the long-term management of patients with diabetes mellitus." This indicates the results are used for medical purposes related to diagnosis, monitoring, or management of a disease.
These points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The VARIANT Express Glycohemoglobin Program is intended for the separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).
Product codes
81LCP
Device Description
The Bio-Rad VARIANT Express Glycohemoglobin Program is designed for use on the Bio-Rad VARIANT Express Instrument. The analytical system, consisting of instrument, software and reagent kit, provides an assay for the separation and percent determination of glycohemoglobin in whole blood.
The VARIANT Express Glycohemoglobin Program is for use on the fully automated VARIANT Express analyzer. The analytical system of instrument and reagent kit provides a means of measuring a mixture of hemoglobins, each formed by the non-enzymatic attachment of circulating blood glucose to a receptive amino acid site on the hemoglobin molecule (HbAo). Attachment of glucose to hemoglobin is achieved in a two step process: formation of an unstable aldimine (Schiff base) intermediate followed by production of a stable ketoamine linkage. Formation of the Schiff base intermediate is a reversible reaction and is influenced by short-term blood glucose fluctuations. In contrast, conversion of the Schiff base intermediate to the "ketoamine" products (Total GHb) is much slower and irreversible. The percentage of total glycated hemoglobin in whole blood is dependent upon the level of sustained blood glucose and is indicative of mean blood glucose over the lifetime of red blood cells (~120 days). Thus, monitoring of total GHb levels has become a routine test for the long-term management of patients with diabetes mellitus.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Bio-Rad VARIANT Express Glycohemoglobin Program was evaluated for precision, measuring range, and accuracy. The precision studies were done according to NCCLS Evaluation protocol, Vol. 12, No 4, EP5-T2, Appendix C, pp 31-39. Using this protocol, precision of the system was determined using a low. medium and high patient. The Within-run % CV for the low was 3.54%, for the Medium 2.90%, and for the High 2.30%. The Between-run % CV for the low was 3.97%. for the medium 4.47% and the high patient 3.55%. Total precision was 5.03% for the low. 4.70% for the medium patient and 3.67 for the high patient. The VARIANT Express Glycohemoglobin Program method meets the precision requirements of the National Glycohemoglobin Standardization Program (NGSP).
A correlation study, to determine accuracy of the Bio-Rad VARIANT Express Glycohemoglobin Program, was done against the Bio-Rad VARIANT Total GHb Program. The study followed NCCLS Document EP9-T. The "r" for the correlation was 0.9895.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Within-run % CV: Low 3.54%, Medium 2.90%, High 2.30%
Between-run % CV: Low 3.97%, Medium 4.47%, High 3.55%
Total precision: Low 5.03%, Medium 4.70%, High 3.67%
Correlation (r): 0.9895
Predicate Device(s)
K941616, K 895661
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3450 Gentamicin test system.
(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.
0
K 712609
Image /page/0/Picture/1 description: The image shows the logo for BIO-RAD. The logo is white text on a black, rounded rectangle. The text is in all caps and bolded.
Bio-Rad Laboratories Diagnostics Group 4000 Alfred Nobel Dr. Hercules, CA 94547-1803 Telephone: 510 724-7000 Fax: 510 741-5824
AUG -6 in
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitter: | Bio-Rad Laboratories, Inc.
Clinical Systems Division
4000 Alfred Nobel Drive
Hercules, California 94547
Phone 1-510-741-6015
FAX 1-510-741-5824 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John W. Nelson
Manager, Regulatory Affairs |
| Date Prepared: | June 30, 1997 |
| Product Trade Name: | Bio-Rad VARIANT™ Express Glycohemoglobin
Program |
| Common Name: | VARIANT Express |
| Classification Name: | Assay, Glycosylated Hemoglobin, 81LCP |
| Predicate Devices | 1. VARIANT Total GHb Program (K941616)
2. Pierce Glycotest II GlyHb Assay Kit (K 895661 |
The Bio-Rad VARIANT Express Glycohemoglobin Program is designed for use on the Bio-Rad VARIANT Express Instrument. The analytical system, consisting of instrument, software and reagent kit, provides an assay for the separation and percent determination of glycohemoglobin in whole blood.
The VARIANT Express Glycohemoglobin Program is for use on the fully automated VARIANT Express analyzer. The analytical system of instrument and reagent kit provides a means of measuring a mixture of hemoglobins, each formed by the non-enzymatic attachment of circulating blood glucose to a receptive amino acid site on the hemoglobin molecule (HbAo). Attachment of glucose to hemoglobin is achieved in a two step process: formation of an unstable aldimine (Schiff base) intermediate followed by production of a stable ketoamine linkage. Formation of the Schiff base intermediate is a reversible reaction and is influenced by short-term blood glucose fluctuations. In contrast, conversion of the Schiff base intermediate to the "ketoamine" products (Total GHb) is much slower and irreversible. The percentage of total glycated hemoglobin in whole blood is dependent upon the level of sustained blood glucose and is indicative of mean blood glucose over the lifetime of red blood cells (~120 days). Thus, monitoring of total GHb levels has become a routine test for the long-term management of patients with diabetes mellitus.
1
To establish substantial equivalence to an existing device, and thus establish the safety and effectiveness of the Bio-Rad VARIANT Express Glycohemoglobin Program , the Bio-Rad VARIANT Express Glycohemoglobin Program has been compared to the Bio-Rad VARIANT Total GHb Program (K941616). A review of the intended use of each system shows them to be the same in that they both measure total qlycosylated hemoglobin in a sample of whole blood using boronate affinity high performance liquid chromatography. The intended use of both the Bio-Rad VARIANT Express Glycohemoglobin Program and the VARIANT Total GHb Program is stated as:.... for the separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC) (see Appendix C and Appendix L).
The underlying technology of VARIANT Express Glycohemoglobin Program and the VARIANT Total GHb Program is the same. Both assay systems use boronate affinity gel chromatography as the separation mechanism; both assay systems use a direct dilution of whole blood in an aqueous medium for sample preparation; and both systems use visible detection at the same wavelength to monitor the hemoglobin.
The performance of the Bio-Rad VARIANT Express Glycohemoglobin Program was evaluated for precision, measuring range, and accuracy. The precision studies were done according to NCCLS Evaluation protocol, Vol. 12, No 4, EP5-T2, Appendix C, pp 31-39. Using this protocol, precision of the system was determined using a low. medium and high patient. The Within-run % CV for the low was 3.54%, for the Medium 2.90%, and for the High 2.30%. The Between-run % CV for the low was 3.97%. for the medium 4.47% and the high patient 3.55%. Total precision was 5.03% for the low. 4.70% for the medium patient and 3.67 for the high patient. The VARIANT Express Glycohemoglobin Program method meets the precision requirements of the National Glycohemoglobin Standardization Program (NGSP).
A correlation study, to determine accuracy of the Bio-Rad VARIANT Express Glycohemoglobin Program, was done against the Bio-Rad VARIANT Total GHb Program. The study followed NCCLS Document EP9-T. The "r" for the correlation was 0.9895.
When considering the similarities of the general characteristics of the two assays (Appendix C), the use of the same technology and the excellent correlation between the two methods, it can be concluded that the VARIANT Express Glycohemoglobin Program and the VARIANT Total GHb Program are substantially equivalent. Based on the establishment of substantial equivalence, the safety and effectiveness of the Bio-Rad VARIANT Express Glycohemoglobin Program is confirmed.
2
APPENDIX C
COMPARISON OF GENERAL CHARACTERISTICS
3
Comparison of General Characteristics of the VARIANT Express Glycohemoglobin Program to the VARIANT Total GHb Program.
| Parameter | VARIANT Express | VARIANT Total GHb |
|---|---|---|
| Glycohemoglobin Program | Program | |
| Analytes Measured/Reported | Total Glycohemoglobin | Total Glycohemoglobin |
| Analyte Reported (optional) | Standardized HbA1c | Standardized HbA1c |
| Calibration | 2 point | 1 point |
| Basic Principle | Affinity chromatography | Affinity chromatography |
| Measurement Type | Quantitative area percent | Quantitative area percent |
| Reagents | Analytical cartridge, pre- | |
| cartridge, elution buffers, | ||
| hemolysis reagent, wash | ||
| reagent, calibrators, whole | ||
| blood primer | Analytical cartridge, elution | |
| buffers, hemolysis reagent, | ||
| wash reagent, calibrators | ||
| Analysis Medium | Alkaline glycylglycine elution | |
| buffer 1, sorbitol/sodium | ||
| citrate buffer 2, silica packed | ||
| cartridge | Alkaline glycylglycine elution | |
| buffer 1, sorbitol/sodium | ||
| citrate buffer 2, silica | ||
| packed cartridge | ||
| Analysis Temperature | 35°C | 35°C |
| Instrumentation | VARIANT Express-Automated | |
| HPLC system for | ||
| glycohemoglobin analysis. | VARIANT Hemoglobin | |
| Testing System- Automated | ||
| HPLC system for | ||
| hemoglobin analysis. | ||
| Sample Type | Whole blood | Whole blood |
| Sample Volume | 5 μL | 5 μL |
| Use of Controls | Two levels of control per run | Two levels of control per run |
4
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 6 1997
Mr. John W. Nelson · Manager, Regulatory Affairs Clinical Systems Division Bio-Rad Laboratories 4000 Alfred Nobel Drive Hercules, CA 94547-1803
Re : K972609 VARIANT Express Glycohemoglobin Proqram Regulatory Class: II Product Code: LCB Dated: July 11, 1997 Received: July 11, 1997
Dear Mr. Nelson:
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 against 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 Requlations.
5
Paqe 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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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
6
Statement of Intended Use
Page 1 of 1
510(k) Number (If Known)
Bio-Rad VARIANT™ Express Glycohemoglobin Program. Device Name:
- The VARIANT Express Glycohemoglobin Program is intended for the Indications for Use: separation and area percent determination of glycohemoglobin (GHb) in whole blood using boronate affinity high performance liquid chromatography (HPLC).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDHR, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Он