# K063068: Ferrara Blood Glucose Monitoring System, Model 631100

- Pathway: 510(k) (Traditional)
- Applicant: Arkray USA, Inc.
- Decided: Dec 20, 2006 after 75 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Advance Micro-draw BGM: named in the summary without a submission number
- (no number) Assure Pro BGM: named in the summary without a submission number

## Most influential descendants
- K091102: Assure Platinum and Glucocard Vital Blood Glucose Monitoring Systems (2009), 0 descendants of its own
- K090653: Pocketchem EZ Blood Glucose Monitoring System (2009), 0 descendants of its own

## Indications for use
The Ferrara Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Ferrara Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or palm. Ferrara Test Strips must be used with the Ferrara Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. For use with Ferrara Blood Glucose Meter and Ferrara Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Source page: https://510kreport.com/device/K063068
Methodology: https://510kreport.com/methodology