HEMOCUE HBA1C 501

K121366 · Infopia Co, Ltd. · LCP · Sep 7, 2012 · Hematology

Device Facts

• Record ID: K121366
• Device Name: HEMOCUE HBA1C 501
• Applicant: Infopia Co, Ltd.
• Product Code: LCP · Hematology
• Decision Date: Sep 7, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HemoCue® HbA1c501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbA Ic is used to monitor long-term glucose control in individuals with diabetes mellitus. HemoCue® Hba1c501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use. The test is for prescription use as an aid in the management of diabetes.

Device Story

HemoCue® HbA1c 501 is an automated boronate affinity assay system for measuring HbA1c percentage in human whole blood. System components include an analyzer, test cartridges, check cartridges, thermal printer, and barcode scanner. Operation involves collecting 4uL of blood into a reagent pack, which lyses erythrocytes and binds hemoglobin and glycated hemoglobin via boronate resin. The cartridge is inserted into the analyzer, where it rotates to place the sample in a measuring zone. Total hemoglobin is measured via diffused reflectance using an LED/photodiode optical sensor; a rinsing solution then washes out non-glycated hemoglobin to allow photometric measurement of glycated hemoglobin. Used in clinical laboratories and point-of-care settings by healthcare professionals to aid in diabetes management. Output provides HbA1c percentage, assisting clinicians in monitoring long-term glucose control.

Clinical Evidence

Clinical performance evaluation conducted to validate professional accuracy. Results demonstrated substantial equivalence to the predicate device. Non-clinical verification and validation activities confirmed system performance, functionality, and reliability met all pre-determined pass/fail criteria.

Technological Characteristics

Quantitative HbA1c monitoring system. Features: analyzer with GUI, barcode scanner for Operator ID, PC connectivity, printer interface. Includes Monthly/Daily Check Cartridges. Software-controlled error reporting. Fundamental technology unchanged from predicate.

Indications for Use

Indicated for quantitative measurement of percent HbA1c in capillary or venous whole blood to monitor long-term glucose control in individuals with diabetes mellitus. Not for diagnosis or screening of diabetes or for neonatal use. Prescription use only.

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

• Clover A1c Glycosylated Hemoglobin Monitor & Blood Glucose Monitor (k082275)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k121366

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable for the HemoCue HbA1c 501 Glycosylated Hemoglobin Monitoring System.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Clover A1c Glycosylated Hemoglobin Monitor & Blood Glucose Monitor (k082275)

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, package labeling, and, if available, 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:
- Change of analyzer appearance.
- Addition of a safe-guard to the Test Cartridge sampling area.
- Change in display resolution and graphic user interface (GUI) design.
- Removal of glucose measurement module from the predicate (k082275).
- Addition of Monthly Check Cartridge.
- Addition of communication feature between the analyzer and PC.
- Addition of expiry date to the barcodes of all cartridges (Test, Monthly Check and Daily Check).
- Change of printer model and addition of Operator ID to the printout.
- Addition of new error codes and renaming of some existing error codes previously associated with the glucose module.
- Addition of barcode scans of Operator ID.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison analysis. Studies performed include method comparison, precision, linearity, specificity, interferences and hemoglobin variants studies.

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

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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.