Predicate Devices

(k) 040872, (k) 063400

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on HPLC technology and chromatographic separation, with no mention of AI or ML terms or concepts.

Therapeutic

No

This device is for the percent determination of hemoglobin A1c in human whole blood to monitor long-term glucose control in individuals with diabetes mellitus. This is a diagnostic function, not a therapeutic one.

Diagnostic

Yes
The device is described as being for "percent determination of hemoglobin A1c in human whole blood" and "Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus." This indicates it provides information used for diagnosis or monitoring of a disease (diabetes), which falls under the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Program" for use with a "Hemoglobin Testing System" which uses "high performance liquid chromatography (HPLC)" and "cation exchange cartridge". This indicates the device is part of a larger hardware system that performs physical analysis of blood samples, not a standalone software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states "percent determination of hemoglobin A1c in human whole blood". This involves testing a sample taken from the human body (whole blood) in vitro (outside the body) to provide information about a physiological state (long-term glucose control in individuals with diabetes mellitus).
Device Description: The description details the use of "human whole blood" and "reagents" for chromatographic separation, which are typical components and processes of an in vitro diagnostic test.
Professional Use Only: While not a definitive marker on its own, the "Professional Use Only" designation is common for IVD devices that require trained personnel to operate and interpret the results.

The core function of analyzing a human biological sample (whole blood) outside the body to diagnose or monitor a medical condition (diabetes mellitus) firmly places this device in the category of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Bio-Rad VARIANT™ II TURBO Link Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC).

The VARIANT II TURBO Link Hemoglobin A1c Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system.

The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is for Professional Use Only.

Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Product codes (comma separated list FDA assigned to the subject device)

LCP, KRZ

Device Description

The VARIANT II TURBO Link Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO Link Hemoglobin A lc Program is based on chromatographic separation of Hemoglobin Alc on a cation exchange cartridge. The reagents in the VARIANT II TURBO Link Hemoglobin A 1c Program have the same formulation as the reagents in the VARIANT II TURBO Hemoglobin A1c Program.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human whole blood

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Professional Use Only.

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)

Accuracy:
Method correlation between the VARIANT II TURBO Link Hemoglobin Alc Program and VARIANT II TURBO Hemoglobin A1c Program was evaluated using 180 EDTA whole blood patient samples ranging from 4.2% to 14.0% HbA1c.

Regression Method	n	R²	Slope	Intercept
Least Squares	180	0.998	0.983	0.225

Precision:
Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.24, No. 25, EP5-A2 (2004) for the VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin Alc Programs. The protocols for both the VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin Alc Programs are similar.
Using these protocols, 40 runs (2 per day) were performed on one VARIANT II TURBO Link (or VARIANT II TURBO) Hemoglobin Testing System over 20 working days. In each duplicate daily run, one aliquot of normal and one aliquot of diabetic patient samples were each analyzed per run.
Although the precision samples are different, since they were run at different time periods, the precision results between the VARIANT II TURBO Link Hemoglobin Alc and the VARIANT II TURBO Hemoglobin Alc Program are equivalent.

Linearity:

	VARIANT II TURBO Link Hemoglobin A1c Program	VARIANT II TURBO Hemoglobin A1c Program
Linear Range	4.1 – 17.6 % HbA1c	4.1 – 16.8 % HbA1c

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Precision (%CV):

	Normal Patient (HbA1c)	Diabetic Patient (HbA1c)
Within run (%CV)	0.62	0.47
Total Precision (%CV)	1.27	0.92

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.

(k) 040872, (k) 063400

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

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).

Summary

0

K070819

JUN 2 5 2007

Summary of Safety and Effectiveness for Bio-Rad Laboratories, Inc.

VARIANT™ II TURBO Link Hemoglobin A1c Program

1

Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

| Submitter: | Bio-Rad Laboratories, Inc.
Clinical Diagnostics Group
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-5309
FAX: (510) 741-6471 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Buckley
Regulatory Affairs Representative |
| Date of Summary Preparation: | March 23, 2007 |
| Device Name: | VARIANT™ II TURBO Link Hemoglobin A1c Program |
| Classification Name: | Assay, Glycosylated Hemoglobin, 81LCP |
| Predicate Device(s): | VARIANT™ II TURBO Hemoglobin A1c Program
(k) 040872
Bio-Rad Laboratories, Inc.
VARIANT™ II TURBO Hemoglobin A1c Program run on the
VARIANT II TURBO Hemoglobin Testing System with CDM 4.0
(k) 063400
Bio-Rad Laboratories, Inc. |
| Intended Use: | The Bio-Rad VARIANT™ II TURBO Link Hemoglobin A1c
Program is intended for the percent determination of hemoglobin
A1c in human whole blood using ion-exchange high performance
liquid chromatography (HPLC).

The VARIANT II TURBO Link Hemoglobin A1c Program is for
use with the VARIANT II TURBO Link Hemoglobin Testing
System interfaced with an automated sample transport system.

The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program
is for Professional Use Only. |

Bio-Rad Laboratories, Inc.
VARIANT II TURBO Link Hemoglobin A1c Program
Page 1 of 4

2

Indications for Use:

Measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Description of the Device:

The VARIANT II TURBO Link Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The VARIANT II TURBO Link Hemoglobin A lc Program is based on chromatographic separation of Hemoglobin Alc on a cation exchange cartridge. The reagents in the VARIANT II TURBO Link Hemoglobin A 1c Program have the same formulation as the reagents in the VARIANT II TURBO Hemoglobin A1c Program.

Technical Characteristics Compared to the Predicate:

The VARIANT II TURBO Link Hemoglobin A1c Program and the predicate VARIANT II TURBO Hemoglobin Alc Program have the same technical characteristics that are summarized in the table below:

| Characteristics | VARIANT II TURBO Link
Hemoglobin A1c Program | VARIANT II TURBO Hemoglobin
A1c Program (k)040872 and
VARIANT II TURBO Hemoglobin
A1c Program run with
CDMTM 4.0(k) 063400 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte Measured: Reported | %Hemoglobin A1c | %Hemoglobin A1c |
| Intended Use | The Bio-Rad VARIANT II TURBO
Link hemoglobin A1c Program is
intended for the percent
determination of hemoglobin A1c in
human whole blood using ion-
exchange high-performance liquid
chromatography (HPLC).
The VARIANT II TURBO Link
Hemoglobin A1c Program is for use
with the VARIANT II TURBO
Link Hemoglobin Testing System
interfaced with an automated
sample transport system.
The Bio-Rad VARIANT II TURBO
link Hemoglobin A1c Program is
for Professional Use Only. | The Bio-Rad VARIANT II TURBO
Hemoglobin A1c Program is intended
for the percent determination of
hemoglobin A1c in human whole blood
using ion-exchange high performance
liquid chromatography (HPLC).
The Bio-Rad VARIANT II TURBO
Hemoglobin A1c Program is intended
for Professional Use Only. For In Vitro
Diagnostic Use. |
| Assay Principle | Cation exchange high performance
liquid chromatography | Cation exchange high performance
liquid chromatography |
| Reagents in kit | The reagent formulations are the
same as the predicate. In addition
Buffer A can be purchased as a
separate kit and Buffer B can be
purchased individually. | Kit contains Analytical cartridge,
Guard cartridge, Buffer A, Buffer B,
Wash/Diluent Solution Set (sold
separately), Whole Blood Primer, and
Calibrator/Diluent Set |

Page 2 of 4

3

| Characteristics | VARIANT II TURBO Link
Hemoglobin A1c Program | VARIANT II TURBO Hemoglobin
A1c Program (k)040872
and (k) 063400 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | Human anticoagulated whole blood
(EDTA) | Human anticoagulated whole blood
(EDTA) |
| Sample transport mode of
operation | Continuous feed, batch or STAT
mode of closed EDTA sample tubes
from automated sample transport
system. | Batch mode of closed EDTA sample
tubes |
| Automated sample transport
system | The VARIANT II TURBO Link
Hemoglobin Testing System
requires an external automated
sample transport system such as
the Sysmex® HST-N
(Hemoglobin Sample Transport)
System. | The VARIANT II TURBO
Hemoglobin Testing System is
complete with an automated sample
conveyor system. |
| Standardization | Traceable to the Diabetes Control
and Complications Trial (DCCT)
reference method and IFCC.
Certified via the National
Glycohemoglobin Standardization
Program (NGSP). | Traceable to the Diabetes Control and
Complications Trial (DCCT)
reference method and IFCC.
Certified via the National
Glycohemoglobin Standardization
Program (NGSP). |

Testing To Establish Substantial Equivalence:

Accuracy:

Method correlation between the VARIANT II TURBO Link Hemoglobin Alc Program and VARIANT II TURBO Hemoglobin A1c Program was evaluated using 180 EDTA whole blood patient samples ranging from 4.2% to 14.0% HbA1c. The results are presented in the following regression table.

| Regression

Method	n	R²	Slope	Intercept
Least Squares	180	0.998	0.983	0.225

Precision:

The following table provides comparison data on the precision between the VARIANT II TURBO Link Hemoglobin Alc and VARIANT II TURBO Hemoglobin A1c Programs, each utilizing low and high EDTA whole blood patient samples, and both tested against samples with normal (6.0,6.2) and high (9.4,12.5) % A1c content.

Method precision was performed using a protocol based on the NCCLS Evaluation protocol, Vol.24, No. 25, EP5-A2 (2004) for the VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin Alc Programs. The protocols for both the VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin Alc Programs are similar.

4

Using these protocols, 40 runs (2 per day) were performed on one VARIANT II TURBO Link (or VARIANT II TURBO) Hemoglobin Testing System over 20 working days. In each duplicate daily run, one aliquot of normal and one aliquot of diabetic patient samples were each analyzed per run.

Although the precision samples are different, since they were run at different time periods, the precision results between the VARIANT II TURBO Link Hemoglobin Alc and the VARIANT II TURBO Hemoglobin Alc Program are equivalent. A summary of combined comparative precision results is presented in the following precision table.

VARIANT II TURBO Link Hemoglobin A1c Program		VARIANT II TURBO Hemoglobin A1c Program
	Normal Patient (HbA1c)	Diabetic Patient (HbA1c)	Normal Patient (HbA1c)	Diabetic Patient (HbA1c)
n= (number of samples)	80	80	80	80
Mean	6.01	9.43	6.2	12.5
Within run (%CV)	0.62	0.47	0.82	0.54
Total Precision (%CV)	1.27	0.92	1.94	2.58

VARIANT II TURBO Link Hemoglobin A1c and VARIANT II TURBO Hemoglobin A1c Precision

Linearity:

| | VARIANT II TURBO Link
Hemoglobin A1c Program | VARIANT II TURBO Hemoglobin
A1c Program |
|--------------|-------------------------------------------------|--------------------------------------------|
| Linear Range | 4.1 – 17.6 % HbA1c | 4.1 – 16.8 % HbA1c |

Conclusion:

When considering the similarities of the intended use, the general characteristics of the use of the same technology and the similar correlation, accuracy and linearity between the two methods, it can be concluded that the VARIANT II TURBO Link Hemoglobin A1c Program is substantially equivalent to the cleared and currently marketed predicate, VARIANT II TURBO Hemoglobin A10 Program.

5

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2007

Bio-Rad Laboratories, Inc. c/o Ms. Jackie H. Buckley 4000 Alfred Nobel Drive Hercules, CA 94547

K070819 Re: Trade Name: Variant II Turbo Link Hemoglobin Testing System Regulation Number: 21 CFR 864.7470 Glycosylated hemoglobin assay Regulation Name: Regulatory Class: Class II Product Code: LCP, KRZ Dated: March 23, 2007 Received: March 26, 2007

Dear Ms. Buckley:

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 vours.

Jean M. Cooper, M.S., D.V.M.

Yean 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

7

Indications for Use

510(k) Number (if known): K070819

Device Name: VARIANT II TURBO Link Hemoglobin A1c Program

Indications For Use:

The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). Measurement of percent hemoglobin A 1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

The VARIANT II TURBO Link Hemoglobin A1c Program is for use with the VARIANT II TURBO Link Hemoglobin Testing System interfaced with an automated sample transport system.

The Bio-Rad VARIANT II TURBO Link Hemoglobin A1c Program is intended for Professional Use Only.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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)

Patricia Bernhardt
Division Sign-Off (for Carol Bensa)

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

510(k) K070819