AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM

K103116 · Bestgen Biotech Corp. · CGA · Mar 13, 2012 · Clinical Chemistry

Device Facts

• Record ID: K103116
• Device Name: AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bestgen Biotech Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AP-2000 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-2000 Blood Glucose Monitoring Systems is intended for testing outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter) [OTC] by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor using glucose oxidase. User applies blood sample to test strip; meter processes signal to display quantitative glucose concentration. Used at home (single-patient) or professional healthcare settings (multi-patient). Multi-patient models require single-use, auto-disabling lancing devices. Healthcare providers use output to monitor diabetes control effectiveness. Benefits include convenient, rapid glucose monitoring for diabetes management.

Clinical Evidence

Bench testing only. System accuracy performance compared to predicate device demonstrated substantial equivalence. Software verification and validation testing confirmed performance, safety, and effectiveness equivalent to predicate.

Technological Characteristics

Electrochemical glucose monitoring. Power: two AAA batteries. Dimensions: 55 x 101 x 18 mm. Weight: 82 g. Features: speaking function. Validated for multi-patient use with Caviwipes Disinfecting Towelettes (EPA reg 46781-8).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger. Intended for single-patient home use (OTC) or multi-patient professional use (multi-models). Aids in monitoring diabetes control. Not for diagnosis/screening of diabetes mellitus. Contraindicated for neonates.

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

• Bestgen Biotech Corporation AP-1000 Blood Glucose Monitoring System (k090389)

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 k103116

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: **Bestgen Biotech Corporation AP-1000 Blood Glucose Monitoring System; k090389**

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 addition of a speaking function
- physical dimensions (from 54 x 93 x 16 mm and 53 g to 55 x 101 x 18 mm and 82 g)
- software modification to accommodate the speaking function
- power supply (from one 3V lithium battery to two AAA batteries)

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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2

The AP-2000, 2010, and 2020 device systems are intended for single-patient use. The AP-2000 multi, 2010 multi, and 2020 multi systems are identical to their "single" counterparts but are designated for multi-patient use. Caviwipes Disinfecting Towelettes with EPA registration number 46781-8 were validated demonstrating complete inactivation of live virus for use with materials from the meters and lancing device. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials of the meters following 18,250 cleaning and disinfection cycles with the meter and 5000 cycles with the lancing device. This testing was designed to simulate 5 years of multiple- and single-patient use for the meter and 5 years of single-patient use for the lancing device. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.