510(k) · Cleared
ClearedPointe Scientific Creatinine Kinase (CK) Reagent Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtest DX · CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
Cleared on Aug 11, 2020 as substantially equivalent to K043202 (Olympus America, Inc., 2004) after a 455-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 11, 2020
- Review
- 455 days
- Class
- Class II
- Product code
- CGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043202 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK043202 Olympus Creatine Kinase Reagent OSR6179/OSR6279Olympus America, Inc. · 2004
- This deviceK191296 Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DX · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043202 | Olympus Creatine Kinase Reagent OSR6179/OSR6279 | Olympus America, Inc. | 2004 | — |
| 0 (this device) | K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | 2020 | — |
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.
- 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 |
|---|---|---|---|
| * | K043202 | Olympus Creatine Kinase Reagent OSR6179/OSR6279Summary page 4…evice Information Predicate Device Olympus Creatine Kinase Reagent Predicate Device Beckman Coulter, Inc. Manufacturer Predicate Device K043202 Premarket Notification #: b. Date Summary Prepared May 10, 2019 Updated on: October 4, 2019 Updated on: Novembe… | 2004 |
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.
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. 2020, 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?
For the quantitative determination of creatine kinase activity in serum and plasma. Rx only.
Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease,
such as progressive Duchenne-type muscular dystrophy.
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/K191296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191296: Pointe Scientific Creatinine Kinase (CK) Reagent Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191296
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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