SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT

K042459 · Beckman Coulter, Inc. · LCP · Nov 17, 2004 · Hematology

Device Facts

• Record ID: K042459
• Device Name: SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: LCP · Hematology
• Decision Date: Nov 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Hemoglobin A1c2 (HbA1c2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood. Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.

Device Story

The SYNCHRON LX® Systems HbA1c2 Reagent is an in vitro diagnostic reagent kit used with SYNCHRON LX® clinical chemistry analyzers. It measures HbA1c concentration as a percentage of total hemoglobin in human whole blood samples. Unlike the predicate, this reagent includes an integrated hemolyzing agent, enabling automated on-line sample preparation within the analyzer, though off-line preparation remains an option. The system processes the sample and provides quantitative results to clinicians. These results serve as a diagnostic tool for monitoring long-term glucose control, dietary efficacy, and therapy management in patients with diabetes mellitus. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data. Performance established via bench testing including precision (NCCLS EP5-A), linearity (NCCLS EP6-A), and method comparison against predicate (Deming regression: y = 0.911x + 0.46, r = 0.991).

Technological Characteristics

Quantitative immunoturbidimetric assay. Components: Hb2 cartridge (hemolyzing agent, colorimetric reagents), A1c2 cartridge (antibodies in buffer), calibrators (human/sheep hemolystate). Connectivity: Integrated with Synchron LX System. Standards: NCCLS EP9-A, EP5-A, EP6-A; prEN ISO 17511 for traceability.

Indications for Use

Indicated for quantitative determination of HbA1c in human whole blood to monitor long-term glucose control in patients with diabetes mellitus.

Regulatory Classification

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.

Predicate Devices

• Synchron LX Systems HbA1c Reagent (k010748)

Submission Summary (Full Text)

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K042459

NOV 17 2004

## 510(k) Summary SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent

#### 1.0 Submitted By:

Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted:

September 8, 2004

#### 3.0 Device Name(s):

#### 3.1 Proprietary Names

SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent

#### 3.2 Classification Name

Glycosylated hemoglobin assay (21 CFR § 864.7470)

#### 4.0 Predicate Device:

| Candidate | Predicate | Manufacturer | Docket<br>Number |
|------------------------------------------|--------------------------------------|--------------------------|------------------|
| SYNCHRON LX<br>Systems<br>HbA1c2 Reagent | SYNCHRON<br>Systems<br>HbA1c Reagent | Beckman<br>Coulter, Inc. | K010748 |

#### 5.0 Description:

The SYNCHRON LX® System(s) HbA1c2 reagent is designed for optimal performance on the SYNCHRON LX® System(s). The reagent kit contains two A1c2 80-test cartridges, one Hb2 160-test cartridge and one

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2 mL bottle each of Hb/A1c2 Calibrator Level 2, A1c2 Calibrator Levels 3, 4 and 5.

#### 6.0 Intended Use:

The Hemoglobin A1c2 (HbA1c2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood.

#### 7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

| Reagent | Aspect/Characteristic | Comments |
|---------|------------------------------------|---------------------------|
| HbA1c2 | Intended Use | Same as Beckman |
| Reagent | Liquid Stable Reagent | SYNCHRON HbA1c<br>Reagent |
| | Analytical Range | |
| | Sample Type | |
| | Reference Intervals | |
| | Shelf Life Stability | |
| | Anticoagulants Used | |
| | Storage Temperature (+2°C to +8°C) | |
| | Interferences | |
| | Specificity | |
| | Sensitivity | |
| | Sample Size | |
| | Methodology | |
| | Formulation | |
| | Calibration | |

### Similarities to the Predicate

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| Reagent | Aspect/<br>Characteristic | Comments |
|-------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HbA1c2<br>Reagent | Sample Preparation | HbA1c2 does not require any sample<br>preparation whereas HbA1c requires manual<br>(off-line) sample preparation; the system<br>automatically prepares the sample (on-line).<br>However, HbA1c2 can be prepared off-line as<br>well. |
| | Limitations | Additional limitations have been added to the<br>HBA1c2 assay that relate to Erythrocyte<br>Sedimentation Rate and proper mixing of whole<br>blood. |
| | Reactive<br>Ingredients | HbA1c2 contains Hemolyzing Reagent in the<br>reagent cartridge itself whereas HbA1c reagent<br>required a customer to hemolyze a sample off-<br>line with separately purchased Hemolyzing<br>Reagent. |

# Differences From The Predicate

#### 8.0 Summary of Performance Data:

.

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

# Method Comparison Study Results

| Instrument | Slope | Intercept | r | n | Comparison Method |
|-------------|-------|-----------|-------|----|-------------------|
| SYNCHRON LX | 0.911 | 0.46 | 0.991 | 80 | SYNCHRON HbA1c |
| SYNCHRON LX | 1.042 | -0.56 | 0.994 | 80 | Tosoh A1c |

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| Sample | Mean<br>(%) | S.D.<br>(%) | %C.V. | N |
|------------------------|-------------|-------------|-------|----|
| Within-Run Imprecision | | | | |
| Normal | 5.5 | 0.07 | 1.2 | 80 |
| Abnormal | 9.8 | 0.09 | 1.0 | 80 |
| Total Imprecision | | | | |
| Normal | 5.5 | 0.14 | 2.6 | 80 |
| Abnormal | 9.8 | 0.27 | 2.8 | 80 |

SYNCHRON LX System HbA1c2 Reagent Imprecision Results

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image is a circular seal with the logo of the U.S. Department of Health and Human Services. The seal features the department's emblem, which is a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 7 2004

Ms. Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Re: k042459

Trade/Device Name: SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: September 8, 2004 Received: September 10, 2004

Dear Ms. Walker:

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sincerely, yours,

Cornelia B. Parks

Cornelia B. Rooks, MA Acting 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): k042459

SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Device Name: Reagent

Indications for Use:

The Hemoglobin A1c2 (HbA1c2) reagent kit, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood.

Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.

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)

Division Sign-Off

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

510k K042459

Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON LX® Systems Hemoglobin A1c2 (HbA1c2) Reagent K042459 Revised Indications for Use, September 2004