510(k) · Cleared
Recalled · Class II · 2014Abx Micros CRP 200, Option IM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horiba Abx · GKZ Counter, Differential Cell
Cleared on Dec 29, 2005 as substantially equivalent to K002646 (Abx Diagnostics, 2000) after a 31-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Dec 29, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002646 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK002646 Abx Micros CRPAbx Diagnostics · 2000
- This deviceK053308 Abx Micros CRP 200, Option IMHoriba Abx · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002646 | Abx Micros CRP | Abx Diagnostics | 2000 | — |
| 0 (this device) | K053308 | Abx Micros CRP 200, Option IM | Horiba Abx | 2005 | — |
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 GKZ? 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 GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · 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 |
|---|---|---|---|
| * | K002646 | Abx Micros CRPSummary page 2…JQP Substantial Equivalence: The ABX MICROS CRP 200 can be considered substantially equivalent to the predicate device ABX MICROS CRP cleared to market under K002646. The fundamental scientific technology for the analyzer itself has not changed. All parameters for complete blood count, differe… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2014 | Class II | Z-1173-2014 | Software design | HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K002646.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The ABX MICROS CRP 200 is an oper tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or in CBC & C-reactive protein (CRP) mode. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders. The MICROS CRP 200 may be coupled, on option, with…
Read the full statement (246 words)
The ABX MICROS CRP 200 is an oper tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or in CBC & C-reactive protein (CRP) mode.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
The MICROS CRP 200 may be coupled, on option, with a information management (iM)system.
The ABX CRP STD is intended to be used for the calibration of the ABX CRP REA reagent on the ABX MICROS CRP 200 hematology analyzer for quantitative determination of C-reactive protein in human whole blood or plasma serum.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
The ABX CRP TROL I & III are intended to be used for the control of the ABX CRP REA reagent on the ABX MICROS CRP 200 hematology analyzer for quantitative determination of C-reactive protein in human whole blood or plasma serum.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
The ASX CRP REA is a quantitative assay for use with the ABX MICROS CRP 200 hematology analyzer for the determination of C-reactive protein in human whole blood or plasma serum.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053308 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053308: Abx Micros CRP 200, Option IM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053308
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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