← Product Code [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP) · K141750

# HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM (K141750)

_Infopia Co, Ltd. · LCP · Jul 24, 2014 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K141750

## Device Facts

- **Applicant:** Infopia Co, Ltd.
- **Product Code:** [LCP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCP.md)
- **Decision Date:** Jul 24, 2014
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.7470
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System is intended for the quantitative determination of HbA1c in human whole blood. The system is intended for use by healthcare professionals in clinical settings.

## Device Story

System performs quantitative HbA1c measurement in human whole blood; utilizes test cartridges for sample analysis. Modifications include aesthetic changes to test/check cartridges to improve usability, color change to daily check cartridge bead window for light intensity verification, shelf-life extension for daily check cartridges, and software updates adding initialization check functions and automatic mode switching post-error. Device operated by healthcare professionals in clinical settings. Output provides HbA1c levels to assist clinical decision-making. Fundamental scientific technology remains unchanged from predicate.

## Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of modified components.

## Technological Characteristics

In-vitro diagnostic monitoring system for HbA1c. Modifications include physical cartridge geometry and color-coded bead windows. Software updates include initialization check functions and automated error recovery modes. Fundamental sensing technology remains consistent with K121366.

## 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

- HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System ([K121366](/device/K121366.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K141750

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of Infopia Co., Ltd.'s previously cleared device HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System, cleared under K121366.
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, system and software operations manuals.
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:
- appearance change of the test cartridge, daily check cartridge and monthly check cartridge to improve usability;
- color change of the bead window on the daily check cartridge to allow light intensity check in daily check cartridge test;
- addition of shelf life for the daily check cartridge;
- addition of a check function at the initialization stage;
- addition of automatic mode change after an error message.

4. Comparison Information (similarities and differences) to applicant'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
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K141750](https://fda.innolitics.com/submissions/CH/subpart-h%E2%80%94hematology-kits-and-packages/LCP/K141750)

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