510(k) · Cleared
ClearedStak-Chex Plus Retics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · GLQ Mixture, Control, White-Cell And Red-Cell Indices
Cleared on Nov 22, 1999 as substantially equivalent to K911582 (Streck Laboratories, Inc., 1991) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Nov 22, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- GLQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905524 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K090137Stak-Chex Plus ReticsStreck · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905524 | Retic-Chex | Streck Laboratories, Inc. | 1991 | — |
| 0 (this device) | K992887 | Stak-Chex Plus Retics | Streck Laboratories, Inc. | 1999 | — |
| +1 | K090137 | Stak-Chex Plus Retics | Streck | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 GLQ? 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? (2)
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 |
|---|---|---|---|
| * | K911582 | Stak-ChexSummary page 1…TaK-Chex Plus Retics Common Name: Assayed hematology control Classification Name: White and red cell (and reticulocyte) control (§ 864.8625) Predicate Device: STaK-Chex (K911582) manufactured by Streck Laboratories Retic-Chex (K905524) manufactured by Streck Laboratories Description: STaK-Chex Plus Retic… | 1991 |
| * | K905524 | Retic-ChexSummary page 1…ol Classification Name: White and red cell (and reticulocyte) control (§ 864.8625) Predicate Device: STaK-Chex (K911582) manufactured by Streck Laboratories Retic-Chex (K905524) manufactured by Streck Laboratories Description: STaK-Chex Plus Retics is a suspension of stabilized human red blood cells, hum… | 1991 |
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 |
|---|---|---|---|
| K090137 | Stak-Chex Plus Retics | 2009 | 0 |
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?
How does its category compare?
All GLQ devicesGLQ Mixture, Control, White-Cell And Red-Cell Indices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GLQ
2in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · GLQ
Too few GLQ 510(k)s in any year since 2007 to give a median.
Recalls per year · GLQ
No recall names GLQ since 2007.
Adverse event reports per year · GLQ
No MAUDE report names GLQ since 2007.
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 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
StaK-Chex Plus Retics is intended to be used as a control for complete blood cell court (CBC), white cell 5-part differential, and reticulocyte parameters on Beckman/Coulter GenS series hematology instruments.
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/K992887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992887: Stak-Chex Plus Retics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992887
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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