← Product Code [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP) · K955087 # HEMOGLOBIN ALC (HBA1C) & TOTAL ASSAYS FOR THE TECHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS (K955087) _Bayer Corp. · LCP · Jun 13, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K955087 ## Device Facts - **Applicant:** Bayer Corp. - **Product Code:** [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP.md) - **Decision Date:** Jun 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7470 - **Device Class:** Class 2 - **Review Panel:** Hematology ## 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. {1} 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. --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K955087](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K955087) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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