510(k) · Cleared
ClearedBblcrystal Gram-Positive ID System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · LQL Gram Positive Identification Panel
Cleared on Feb 4, 1997 as substantially equivalent to K813614 (Dms Laboratories, 1982) and 2 other predicates after a 260-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Feb 4, 1997
- Review
- 260 days
- Class
- Class I
- Product code
- LQL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K813614 (1982). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK813614 Staph TracDms Laboratories · 1982
- This deviceK961968 Bblcrystal Gram-Positive ID SystemBd Becton Dickinson Vacutainer Systems Preanalytic · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813614 | Staph Trac | Dms Laboratories | 1982 | — |
| 0 (this device) | K961968 | Bblcrystal Gram-Positive ID System | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K813614 | Staph TracSummary page 1…rganism ID System Classification Name: Microbiology - Discs, Strips, and Reagents, Microorganism Differentiation PREDICATE DEVICES: BioMerieux Vitek, Inc., APl Staph (K813614) BioMerieux Vitek, Inc., APl 20 Strep (K813610) BioMerieux Vitek, Inc., APl Coryne (K910304) DEVICE DESCRIPTION: INTENDED USE:… | 1982 |
| * | K813610 | Rapid StrepSummary page 1…logy - Discs, Strips, and Reagents, Microorganism Differentiation PREDICATE DEVICES: BioMerieux Vitek, Inc., APl Staph (K813614) BioMerieux Vitek, Inc., APl 20 Strep (K813610) BioMerieux Vitek, Inc., APl Coryne (K910304) DEVICE DESCRIPTION: INTENDED USE: The BBLCRYSTAL™ Gram Positive (GP) Identificati… | 1982 |
| * | K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaSummary page 1…anism Differentiation PREDICATE DEVICES: BioMerieux Vitek, Inc., APl Staph (K813614) BioMerieux Vitek, Inc., APl 20 Strep (K813610) BioMerieux Vitek, Inc., APl Coryne (K910304) DEVICE DESCRIPTION: INTENDED USE: The BBLCRYSTAL™ Gram Positive (GP) Identification (ID) System is a miniaturized identificati… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All LQL devicesLQL Gram Positive Identification Panel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQL
FDA has decided no LQL device since 2007.
Median 510(k) review, days · LQL
Too few LQL 510(k)s in any year since 2007 to give a median.
Recalls per year · LQL
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LQL
23in 2025
MAUDE reports naming product code LQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 0 | — | 1 | 89 |
| 2018 | 0 | — | 0 | 70 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 2 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 23 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961968: Bblcrystal Gram-Positive ID System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961968
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026