# K961968: Bblcrystal Gram-Positive ID System

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Feb 4, 1997 after 260 days
- Product code: LQL (Gram Positive Identification Panel)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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 K813614 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813614: Staph Trac, Dms Laboratories (1982) Summary page 1.
- K813610: Rapid Strep, Dms Laboratories (1982) Summary page 1.
- K910304: Rapid Coryne Syst/Identif of Coryneform Bacteria, Vitek Systems, Inc. (1991) Summary page 1.

## Indications for use
Use of the BBLCRYSTAL™ Gram Positive Identification System is indicated when the aerobic gram-positive organisms described in the attached table have been isolated in pure culture from clinical specimens in a clinical laboratory, and identification of the microorganisms is desired.

Source page: https://510kreport.com/device/K961968
Methodology: https://510kreport.com/methodology