(69 days)
Not Found
No
The description focuses on standard HPLC technology and data processing, with no mention of AI or ML algorithms for analysis or interpretation.
No
This device is for in vitro diagnostic use, intended for the separation and analysis of hemoglobins in whole blood to aid in the identification of abnormal hemoglobins. It does not directly treat or diagnose a disease state.
Yes
The device is specifically stated to be "for in vitro diagnostic use only" and its intended use is to "aid in the identification of abnormal hemoglobins in whole blood," which directly points to a diagnostic function.
No
The device description clearly states that the VARIANT™ II is a "fully automated HPLC system" and describes hardware components like the Sampling Station (VSS), chromatographic station (VCS) with dual pumps, analytical cartridge, and filter photometer. While it mentions "Clinical Data Management(CDM) software," this software is part of a larger hardware system for data reduction and report generation, not a standalone software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Intended Use: The device is intended for the separation and area percent determinations of hemoglobins and aid in the identification of abnormal hemoglobins in whole blood. This is a test performed on a biological sample taken from the body, which is a key characteristic of an in vitro diagnostic.
- Device Description: The description details a system that analyzes a sample (whole blood) using chemical and physical processes (ion-exchange high performance liquid chromatography) to provide diagnostic information (hemoglobin levels and identification of abnormal hemoglobins).
These points strongly indicate that the device is designed to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VARIANT™ II β-thalassemia Program is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The VARIANT™ II β-thalassemia Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System
For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JPD
Device Description
The VARIANT™ II is a fully automated HPLC system which can be used to separate and determine area percentages for hemoglobins A, and F and to provide qualitative determinations of abnormal hemoglobins.
The VARIANT™ II B-thalassemia Short Program utilizes principles of ion exchange high performance liquid chromatography(HPLC). The samples are automatically mixed and diluted on the VARIANT™ II Sampling Station(VSS) and injected into the analytical cartridge. This is a change from the unmodified program(VARIANT) where samples had to be mixed and diluted manually before being placed on the instrument. The VARIANT™ II chromatographic station(VCS) dual pumps deliver a programmed buffer gradient of increasing ionic strength to the cartridge, where the HbA, F are separated based on their ionic interactions with the cartridge material. The separated HbA. F then pass through the flow cell of the filter photometer, where changes in the absorbance at 415 nm are measured. An additional filter at 690 nm corrects the background absorbance. The VARIANT™ II Clinical Data Management(CDM) software performs reduction of raw data collected from each analysis. One level calibration is used for the adjustment of the calculated HbAyF values. A patient sample report and a chromatogram are generated by CDM for each sample. Minor differences in the separation efficiency of individual analytical cartridges are corrected by the use of the Hemoglobin A /F Calibrator.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing described in Section F of this submission focuses on performance characteristics of VARIANT™ II ß-Thal Short. Testing met all acceptance criteria.
When considering the similarities of the intended use, characteristics of the two VARIANT ß-thalassemia programs, the use of the same technology, and the excellent concordance between the two methods, it can be concluded that the VARIANT and the VARIANT II B-thalassemia programs are substantially equivalent. Based on the establishment of substantial equivalence, the safety and effectiveness of the VARIANT II ß-thalassemia program is confirmed.
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
§ 864.7400 Hemoglobin A
2 assay.(a)
Identification. A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).(b)
Classification. Class II (performance standards).
0
K99川27
JUN 1 0 1999
Special 510(k): Device Modification Summary
| Submitter: | Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-6188
FAX: (510) 741-6471 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Juliet Carrara
Regulatory Affairs/Quality Assurance Manager |
| Date of Summary Preparation: | March 29, 1999 |
| Device Name: | VARIANT™ II β-thalassemia |
| Classification Name: | Class II, 81JPD Hemoglobin A₂ Quantitation |
| Unmodified Device: | VARIANT™ β-thalassemia
K924122
Bio-Rad Laboratories
Hercules, CA 94547 |
| Statement of Intended Use: | The VARIANT™ II β-thalassemia Program is
intended for the separation and area percent
determinations of hemoglobins A2 and F and as an
aid in the identification of abnormal hemoglobins in
whole blood using ion-exchange high performance
liquid chromatography (HPLC). |
| | The VARIANT™ II β-thalassemia Program is
intended for use only with the Bio-Rad
VARIANT™ II Hemoglobin Testing System |
| | For in vitro diagnostic use only. |
1
Description of Device
The VARIANT™ II is a fully automated HPLC system which can be used to separate and determine area percentages for hemoglobins A, and F and to provide qualitative determinations of abnormal hemoglobins.
The VARIANTM II B-thalassemia Short Program utilizes principles of ion exchange high performance liquid chromatography(HPLC). The samples are automatically mixed and diluted on the VARIANT™ II Sampling Station(VSS) and injected into the analytical cartridge. This is a change from the unmodified program(VARIANT) where samples had to be mixed and diluted manually before being placed on the instrument. The VARIANT™ II chromatographic station(VCS) dual pumps deliver a programmed buffer gradient of increasing ionic strength to the cartridge, where the HbA, F are separated based on their ionic interactions with the cartridge material. The separated HbA. F then pass through the flow cell of the filter photometer, where changes in the absorbance at 415 nm are measured. An additional filter at 690 nm corrects the background absorbance. The VARIANT™ II Clinical Data Management(CDM) software performs reduction of raw data collected from each analysis. One level calibration is used for the adjustment of the calculated HbAyF values. A patient sample report and a chromatogram are generated by CDM for each sample. Minor differences in the separation efficiency of individual analytical cartridges are corrected by the use of the Hemoglobin A /F Calibrator.
Technical Characteristics Compared to Unmodified Device
The main difference between the VARIANT™ and VARIANT™ II involves the patient sample preparation. In VARIANT™ II the preparation is automated, in VARIANT™ the preparation is manual.
| Technical Characteristic | VARIANT I | VARIANT II |
|---|---|---|
| Sample Preparation: | ||
| Calibrator and controls | Manual Preparation. | Manual Preparation |
| Sample Preparation: | ||
| Patient Samples | Manual Preparation. | Automatic Preparation |
| Run SET UP | Run sequence is programmed | |
| manually. | Run sequence read from bar | |
| codes. |
2
| Technical
| Characteristic | VARIANT | VARIANT II |
|---|---|---|
| STAT Samples | Available. | Not Available. |
| Analyte Identification | Analyte peaks are labelled. | Analyte peaks are labelled. |
| Calibration | Calibration response factors are used to adjust observed values. | Calibration response factors are used to adjust observed values. |
| Data Retrieval | Chromatograms are not stored in the database. | Chromatograms are stored in the database. |
| Reanalysis | Not available | Available |
| Sample Identification | Manual identification | Barcode identification |
| Summary Report | Not available | Available |
·
.
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6
3
Performance Characteristics
Testing described in Section F of this submission focuses on performance characteristics of VARIANT™ II ß-Thal Short. Testing met all acceptance criteria.
When considering the similarities of the intended use, characteristics of the two VARIANT ß-thalassemia programs, the use of the same technology, and the excellent concordance between the two methods, it can be concluded that the VARIANT and the VARIANT II B-thalassemia programs are substantially equivalent. Based on the establishment of substantial equivalence, the safety and effectiveness of the VARIANT II ß-thalassemia program is confirmed.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, depicted with three curved lines.
JUN 1 0 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Juliet Carrara Regulatory Affairs and Quality Assurance Manager Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, California 94547
Re: K991127
Trade Name: VARIANT™ II ß-thalassemia Short Program Regulatory Class: II Product Code: JPD Dated: May 28, 1999 Received: June 3, 1999
Dear Ms. Carrara:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 regulations.
5
Page 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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 Indications for Use
510(k) Number:
Device Name:
Indications for Use:
Bio-Rad VARIANT™ II ß-thalassemia
The VARIANT™ II ß-thalassemia Program is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The VARIANT™ II ß-thalassemia Program is intended for use only with the Bio-Rad VARIANT™ II Hemoglobin Testing System
For in vitro diagnostic use only.
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE | ||
|---|---|---|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
| (Division Sign-Off) | ||
| Division of Clinical Laboratory Devices | ||
| 510(k) Number K991127 | ||
| Prescriptive Use | OR over-the-counter Use | |
| (Per 21 CFR 801.109) |