510(k) · Cleared
ClearedNRBC-Chex for Advia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck · GJR Control, Red-Cell
Cleared on Feb 5, 2008 as substantially equivalent to K060083 (Streck, 2006) after a 33-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 5, 2008
- Review
- 33 days
- Class
- Class II
- Product code
- GJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000945 (2000). 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 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 GJR? 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 |
|---|---|---|---|
| * | K060083 | NRBC-Chex for LHSummary page 1…Assayed Hematology Control Classification Name: Nucleated Cell and Red Blood Cell Control (864.8625) Predicate Device: nRBC-Chex for LH (K060083) Manufactured by Streck Description: nRBC-Chex for ADVIA® is stabilized suspension of human and animal blood, in a solution cont… | 2006 |
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 8 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GJR devicesGJR Control, Red-Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · GJR
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · GJR
Too few GJR 510(k)s in any year since 2007 to give a median.
Recalls per year · GJR
No recall names GJR since 2007.
Adverse event reports per year · GJR
No MAUDE report names GJR 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 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 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
nRBC-Chex for ADVIA® is an assayed whole blood control designed to evaluate the accuracy and
precision of the Siemens Healthcare Diagnostics Inc. hematology analyzers in the measurement of
the nucleated red blood cell parameter. Refer to product assay sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080016 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080016: NRBC-Chex for Advia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080016
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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