RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)

K081975 · Abbott Diabetes Care, Inc. · NBW · Nov 26, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081975
• Device Name: RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT)
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, or upper arm. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

Device Story

ReliOn Ultima Advance Blood Glucose Monitoring System measures glucose in fresh capillary whole blood; utilizes amperometric biosensor technology on disposable test strips; reagent uses glucose dehydrogenase with nicotinamide-adenine dinucleotide (GDH-NAD). Device intended for home or professional use; patient performs finger/forearm/thumb stick; applies blood to strip. Meter processes electrical current generated by reaction; converts current to glucose reading using pre-programmed calibration slope; eliminates need for manual calibration bar required by predicate. Output displayed on meter screen; assists patients and clinicians in diabetes management decisions.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to predicate.

Technological Characteristics

Amperometric glucose monitoring system; hard-coded calibration; test strip methodology consistent with predicate. No ketone testing capability. Designed for home use.

Indications for Use

Indicated for people with diabetes for quantitative capillary whole blood glucose monitoring to aid in diabetes management. Not for neonatal use or diabetes diagnosis/screening.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Precision Xtra (K051213)

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 K081975 ReliOn Ultima
Advance Blood Glucose Monitoring System

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.) k051213
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: the Precision Xtra meter is being modified to a hard coded calibration and ketones are not available on this modified meter. The name has changed to the ReliOn Ultima Advance meter. The test strips will be called the ReliOn Advance Test Strips. There has been no change in test strip methodology from the predicate to the candidate for this device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and coding requirements.
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. The sponsor used 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.

Comments
Validation Protocols were adequate to address the identified causes of hazards identified in the Risk Analysis (FMEA)