HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS

K955087 · Bayer Corp. · LCP · Jun 13, 1996 · Hematology

Device Facts

• Record ID: K955087
• Device Name: HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
• Applicant: Bayer Corp.
• Product Code: LCP · Hematology
• Decision Date: Jun 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Hemoglobin A1c	—	—	Precision: 2.0-3.1% CV; Correlation: y = 1.09x - 0.39 (r=0.99); Analytical Range: 2.5-18%	—	—	—	—
Total Hemoglobin	—	—	Precision: 0.6-0.9% CV; Correlation: y = 0.96x + 0.13 (r=0.988); Analytical Range: 7-23 g/dL	—	—	—	—

Indications for Use

This in vitro diagnostic method is intended to quantitatively measure Hemoglobin A1c (HbA1c) and Total Hemoglobin (Thb) in human blood on the Technicon RA family/opeRA instrument systems. Measurements obtained through this procedure can be used for monitoring the long-term care of persons with diabetes.

Device Story

In vitro diagnostic assay for Technicon RA/opeRA instrument systems; measures HbA1c and Total Hemoglobin in human blood samples. Used in clinical laboratory settings by trained personnel. Provides quantitative results to clinicians for monitoring long-term glycemic control in diabetic patients. System utilizes automated photometric analysis to determine hemoglobin concentrations; results assist in clinical decision-making regarding diabetes management.

Clinical Evidence

Bench testing only. Comparison study (n=154) against Ames DCA 2000 showed correlation r=0.99, y=1.09x-0.39. Precision studies demonstrated total CV% between 2.0% and 3.1% across HbA1c ranges of 5.7-11.6%. Total Hemoglobin performance compared to NCCLS reference method (n=50) showed r=0.988.

Technological Characteristics

In vitro diagnostic assay reagents for use on Technicon RA/opeRA automated photometric instrument systems. Analytical range: HbA1c 2.5-18%, Total Hemoglobin 7-23 g/dL.

Indications for Use

Indicated for quantitative measurement of HbA1c and Total Hemoglobin in human blood for monitoring long-term care of patients with diabetes.

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

• Ames DCA 2000 Hemoglobin method

Reference Devices

• NCCLS Reference Method (Document H15-A2, Vol 14, No. 6, May 1994)

Submission Summary (Full Text)

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K955087
Enclosure 8
JUN 13 1996
Attachment 3

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Hemoglobin A1c (%)

Listed below is a comparison of the performance between the Technicon RA®/opeRA™ Systems Hemoglobin A1c/Total Hemoglobin assays and the similar device assay system that was granted FDA clearance of substantial equivalence (Ames DCA 2000® Hemoglobin method). The information provided in this summary was extracted from the Technicon RA®/opeRA™ Systems Hemoglobin A1c/Total Hemoglobin method sheet and the Ames DCA 2000® Hemoglobin A1c method sheet (Attachments 1 & 2).

## INTENDED USE

This *in vitro* diagnostic method is intended to quantitatively measure Hemoglobin A1c (HbA1c) and Total Hemoglobin (Thb) in human blood on the Technicon RA family/opeRA instrument systems. Measurements obtained through this procedure can be used for monitoring the long-term care of persons with diabetes.

| METHOD | RA/opeRA HbA1c | | DCA 2000 HbA1c | |
| --- | --- | --- | --- | --- |
| Precision | Mean % | Total CV% | Mean % | Total CV % |
| | 5.7 | 3.1 | 5.2 | 3.5-5.6 |
| | 8.9 | 2.6 | 8.2 | 2.4-4.9 |
| | 11.6 | 2.0 | 12.0 | 3.3-4.9 |
| Analytical
Range | 2.5 - 18% | | 2.5 - 14.0% | |
| Correlation
y = RA/opeRA
x = DCA 2000 | y = 1.09 x -0.39
n = 154
r = 0.99
Syx = 0.36 | | | |
| Expected
Values | 4.4 - 6.0 % | | 4.5 - 5.7% | |

updated 5/21/96,gm.

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Attachment 3

# SUMMARY OF SAFETY AND EFFECTIVENESS

## Total Hemoglobin (g/dl)

| METHOD | RA/opeRA, Thb | NCCLS Reference Method, Thb
Document H15 - A2, Vol 14, No. 6,
May 1994 |
| --- | --- | --- |
| Precision | Mean g/dL Within-Run CV% | |
| | 10.6 | 0.6 |
| | 15.3 | 0.7 |
| | 18.6 | 0.9 |
| Analytical
Range | 7 - 23 g/dL | |
| Correlation | y = RA/opeRA
x = NCCLS method | y = 0.96 x 0.13
n = 50
r = 0.988
Syx = 0.65 |
| Expected
Values | 12.3 - 17.9 g/dL | |

updated 5/21/96,gm.