510(k) · Cleared
ClearedCD4 Count
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · GGL Control, White-Cell
Cleared on Feb 11, 2009 as substantially equivalent to K051633 (Streck, 2005) after a 42-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Feb 11, 2009
- Review
- 42 days
- Class
- Class II
- Product code
- GGL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920997 (1992). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GGL? 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? (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 |
|---|---|---|---|
| * | K051633 | CD-Chex Plus BCSummary page 1…CD4 Count Common Name: Immunophenotyping Control Classification Name: White Cell Control, 21CFR864.8625 Predicate Device: CD-Chex® Plus BC (K051633) Description: CD4 Count is a suspension of stabilized human blood packaged in a plastic vial containing 2.5 mL vol… | 2005 |
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GGL devicesGGL Control, White-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GGL
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GGL
Too few GGL 510(k)s in any year since 2007 to give a median.
Recalls per year · GGL
No recall names GGL since 2007.
Adverse event reports per year · GGL
1in 2023
MAUDE reports naming product code GGL, 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 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
CD4 Count is intended to be used as an assayed whole blood quality control for evaluating white blood cell subsets on a flow cytometry instrument
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K083926 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083926: CD4 Count.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083926
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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