← Product Code [PDJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PDJ) · K200256 # ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay (K200256) _Siemens Healthcare Diagnostics, Inc. · PDJ · Jul 2, 2021 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PDJ/K200256 ## Device Facts - **Applicant:** Siemens Healthcare Diagnostics, Inc. - **Product Code:** [PDJ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PDJ.md) - **Decision Date:** Jul 2, 2021 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 862.1373 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry Systems. Measurement of Hemoglobin A 1 c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus. ## Device Story ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic test for quantitative determination of HbA1c in human anticoagulated venous whole blood and hemolysate. Device operates on ADVIA® Chemistry Systems; utilizes enzymatic methodology to measure HbA1c levels. Assay consists of three liquid, ready-to-use reagents (R1, R2, and Pretreatment Solution). Automated application lyses whole blood specimens on-system; manual application uses Pretreatment Solution to create hemolysate. Healthcare professionals use results to aid in diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus and identification of at-risk patients. Modification extends low end of analytical measuring range for total hemoglobin (tHb). ## Clinical Evidence Bench testing only. Verification and validation activities performed based on risk analysis to confirm performance following the modification of the total hemoglobin measurement range. ## Technological Characteristics Quantitative enzymatic assay. Reagents: R1, R2, and Pretreatment Solution. Measuring range: 3.8-14.0% HbA1c (DCCT/NGSP); 18.03-129.50 mmol/mol HbA1c (IFCC). Total hemoglobin analytical measuring range: 74.74-320.15 μmol/L. Instrument platform: ADVIA® 1800 Clinical Chemistry System. Standardization: Traceable to IFCC reference calibrators; NGSP certified. ## Regulatory Identification A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus. ## Special Controls (b) Classification. Class II (special controls). Hemoglobin A1c test systems must comply with the following special controls: 1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. 2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity and interference, including the following: i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0%, 6.5%, 8.0% and 12% hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least 3 lots of the device and 3 instruments, as applicable. ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the new device and compare results of the new device to results of the standardized test method. Results must demonstrate little or no bias versus the standardized method. iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6%. iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2 and Hemoglobin S. 3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations. *Classification.* Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA. (2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following: (i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable. (ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method. (iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent. (iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S. (3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations. ## Predicate Devices - ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay ([K171771](/device/K171771.md)) ## 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} SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I Background Information: A 510(k) Number K200256 B Applicant Siemens Healthcare Diagnostics, Inc. C Proprietary and Established Names ADVIA® Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | LCP | Class II | 21 CFR 864.7470 - Glycosylated Hemoglobin Assay | HE - Hematology | | PDJ | Class II | 21 CFR 862.1373 - Hemoglobin A1c test system | CH - Clinical Chemistry | II Review Summary: This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable. 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. k171771, ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay 2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for a modification of the lower end of the total hemoglobin measurement range, from 88.98 μmol/L to 74.74 μmol/L. 4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PDJ/K200256](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/PDJ/K200256) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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