RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01

K083223 · Abbott Diabetes Care, Inc. · LFR · Apr 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083223
• Device Name: RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Apr 16, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Abbott ReliOn Ultima Blood Glucose Monitoring System is intended for use in 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 in monitoring the effectiveness of diabetes control programs. It is not intended for the diagnosis of or screening for diabetes mellitus, nor for use on neonates.

Device Story

ReliOn Ultima Blood Glucose Monitoring System; modified from lot-variable calibration to fixed-lot calibration. System measures glucose in capillary whole blood; used by patients with diabetes for self-monitoring. Device utilizes test strips; methodology remains unchanged from predicate. Modification involves calibration process; fundamental scientific technology remains consistent with previously cleared device. Healthcare providers use results to assess diabetes control effectiveness.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures; FMEA used to assess modification impact. Results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system. Amperometric sensing technology. Modification: fixed lot calibration replacing lot-variable calibration. No changes to test strip methodology or fundamental scientific technology.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood from the finger, palm, or forearm by people with diabetes as an aid in monitoring the effectiveness of diabetes control programs.

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

• Abbott Precision Xtra Plus (k051213)
• Optium Plus Blood Glucose Test Strips (k051213)

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 k083223

Abbott ReliOn Ultima 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. k051213, Abbott Precision Xtra Plus, or Optium Plus Blood Glucose Test Strips
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 calibration of the ReliOn Ultima system from a lot variable calibration to a fixed lot calibration.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and coding requirements. There are no changes to how the User performs the calibration function or testing, nor changes to test strip methodology.

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.