# K991075: Atlast Glucose Control Solution

- Pathway: 510(k) (Traditional)
- Applicant: Amira Medical, Inc.
- Decided: May 10, 1999 after 40 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944459 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944459: Accu-Chek Instant Plus G-C/DM Blood Glucose Monitoring System, Boehringer Mannheim Corp. (1996) Summary page 1.

## Indications for use
An assayed control solution for use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.

Source page: https://510kreport.com/device/K991075
Methodology: https://510kreport.com/methodology