A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC

K090413 · Bayer Healthcare, LLC · LCP · May 14, 2009 · Hematology

Device Facts

• Record ID: K090413
• Device Name: A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC
• Applicant: Bayer Healthcare, LLC
• Product Code: LCP · Hematology
• Decision Date: May 14, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The A1CNow multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c, %A1C) levels in whole blood samples. The test is for home use and professional use for monitoring glycemic control in people with diabetes.

Device Story

Bayer A1CNow+ (Professional) and Bayer A1CNow Self Check (OTC) are diagnostic devices for HbA1c measurement. Modifications include updated sampling device design and increased test cartridge stability. Device operates via immunoassay technology to quantify HbA1c from blood samples. Used in clinical settings or by patients at home. Output provides HbA1c percentage to assist in diabetes management and glycemic control monitoring. Fundamental scientific technology remains consistent with the predicate device.

Clinical Evidence

Performance assessed in two separate clinical validation studies. Results demonstrated that modifications to the hemolysate kit and product stability had no negative impact on safety or efficacy. Verification and validation studies confirmed the product is safe and effective for use by both lay users and healthcare professionals.

Technological Characteristics

Quantitative assay for %HbA1c using dry reagent strips. System includes a semi-disposable plastic-encased monitor, plastic cartridge, and sample dilution kit. Operates via chemical reaction with whole blood samples; results displayed on LCD. No changes to fundamental scientific technology from predicate.

Indications for Use

Indicated for professional and OTC use for the measurement of HbA1c levels.

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

• Bayer A1CNow+ (K051321)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k090413

Bayer A1CNow+ (Professional Use), Bayer A1CNow Self Check (OTC Use)

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 (delete/add items as necessary):

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.) k051321
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 modification to the sampling device design and modifications to increase test cartridge stability and name change for the OTC device to Bayer A1CNow Self Check.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, NGSP certification, and user 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 FMEA
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.