510(k) · Cleared
Recalled · Class II · 2017Cyto-Chex BCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on Jul 31, 2008 as substantially equivalent to K040107 (Streck Laboratories, Inc., 2004) after a 154-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 31, 2008
- Review
- 154 days
- Class
- Class II
- Product code
- GIM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030596 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK030596 Immunicon Cellsave Preservative TubeImmunicon Corp. · 2003
- 1 generation backK040107 Cyto-Chex BCTStreck Laboratories, Inc. · 2004
- This deviceK080552 Cyto-Chex BCTStreck · 2008
- Descendant · cites it directly · 0 of its ownK162723 TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K162723TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030596 | Immunicon Cellsave Preservative Tube | Immunicon Corp. | 2003 | — |
| −1 | K040107 | Cyto-Chex BCT | Streck Laboratories, Inc. | 2004 | — |
| 0 (this device) | K080552 | Cyto-Chex BCT | Streck | 2008 | — |
| +1 | K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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 GIM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GIM device
- #1 K240455 BD Vacutainer® Citrate Blood Collection Tubesscore 8.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K040107 | Cyto-Chex BCTSummary page 1…Blood specimen collection device Classification Name: Blood specimen collection device, 21CFR862.1675 Predicate Device: Cyto-Chex® BCT, K040107 Description: Cyto-Chex BCT consists of a standard 13 x 75mm glass blood collection tube containing 75.8ul of sterile K3EDTA anti… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 23, 2017 | Class II | Z-1684-2017 | Error in labeling | Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K162723 (Caltag Medsystems, Ltd., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GIM devicesGIM Tubes, Vacuum Sample, With Anticoagulant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GIM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GIM
Too few GIM 510(k)s in any year since 2007 to give a median.
Recalls per year · GIM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIM
641in 2025
MAUDE reports naming product code GIM, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 276 |
| 2019 | 0 | — | 0 | 145 |
| 2020 | 0 | — | 0 | 147 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 316 |
| 2025 | 0 | — | 1 | 641 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cyto-Chex ® BCTTM is intended for collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 14-day period following collection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080552: Cyto-Chex BCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080552
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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