510(k) · Cleared
ClearedRandox Liquid CK-MB, Randox CK-MB Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Nov 21, 2013 as substantially equivalent to K003158 (Roche Diagnostics Corp., 2000) after a 330-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Nov 21, 2013
- Review
- 330 days
- Class
- Class II
- Product code
- CGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003158 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003158 Roche Diagnostics CK-MBRoche Diagnostics Corp. · 2000
- This deviceK123977 Randox Liquid CK-MB, Randox CK-MB CalibratorRandox Laboratories, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003158 | Roche Diagnostics CK-MB | Roche Diagnostics Corp. | 2000 | — |
| 0 (this device) | K123977 | Randox Liquid CK-MB, Randox CK-MB Calibrator | Randox Laboratories, Ltd. | 2013 | — |
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 CGS? 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 CGS device
- #1 K191296 Pointe Scientific Creatinine Kinase (CK)…score -0.2 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K003158 | Roche Diagnostics CK-MBSummary page 2…AND 510 (k) NUMBER Predicate Device Proprietary Name: Roche Diagnostics OK-MB reagent, Roche Diagnostics OK-MB calibrator for automated systems. 510 (k) Number: K003158 5. INTENDED USE The OK-MB test system is a device intended for the quantitative in vitro determination of OK-MB concentrat… | 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K003158.
How does its category compare?
All CGS devicesCGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · CGS
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CGS
Too few CGS 510(k)s in any year since 2007 to give a median.
Recalls per year · CGS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGS
2in 2025
MAUDE reports naming product code CGS, 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 | 1 | — | 1 | 64 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1,434 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 1 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Randox Liquid CK-MB
The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola.
Randox CK-MB Calibrator
The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods
The Randox Liquid CK-MB test system for the RX Imola and RX Daytona is a prescription use device intended to be used in clinical laboratories only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123977: Randox Liquid CK-MB, Randox CK-MB Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123977
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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