510(k) · Cleared
ClearedStat Profile Prime Plus Analyzer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nova Biomedical Corporation · CGA Glucose Oxidase, Glucose
Cleared on Mar 13, 2020 as substantially equivalent to K180340 (Nova Biomedical Corporation, 2018) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Mar 13, 2020
- Review
- 30 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K061830 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK061830 Stat Profile Critical Care Xpress (CCX), Model 1+Nova Biomedical Corp. · 2006
- 2 generations backK110648 Nova Stat Profile Phox Ultra Analyzer SystemNova Biomedical Corporation · 2011
- 1 generation backK180340 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2018
- This deviceK200349 Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061830 | Stat Profile Critical Care Xpress (CCX), Model 1+ | Nova Biomedical Corp. | 2006 | — |
| −2 | K110648 | Nova Stat Profile Phox Ultra Analyzer System | Nova Biomedical Corporation | 2011 | — |
| −1 | K180340 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018 | — |
| 0 (this device) | K200349 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K180340 | Stat Profile Prime Plus Analyzer SystemSummary page 4…FR § 862.1450 Lactic Acid Test System * Class I KHP * Meets Limitations to Exemptions 21 CFR § 862.9(c)(9) Predicate Device: k180340 – Stat Profile Prime Plus Analyzer System Purpose: Modification of a previously cleared device (k180340) – modify the intended u… | 2018 |
| * | K110648 | Nova Stat Profile Phox Ultra Analyzer SystemSummary page 7…esting was completed to show that the Stat Profile Prime Plus Analyzer System demonstrates substantial equivalence to the Stat Profile pHOx Ultra Analyzer System (K110648). In this submission, only Lactate data for detection limit, linearity, and interference/specificity was reviewed. Perform… | 2011 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea Nitrogen in heparinized arterial and venous whole blood. Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic…
Read the full statement (121 words)
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory
settings and for point-of-care usage for quantitative determination of Glucose, Lactate, Creatinine, and Blood Urea
Nitrogen in heparinized arterial and venous whole blood.
Glucose measurement is used in the diagnosis and treatment of carbohydrate
metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and
idiopathic hypoglycemia, and of pancreatic islet cell carcinoma
Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients
suspected of having lactic acidosis
Creatinine measurement is used in the diagnosis and treatment of certain renal
conditions and for monitoring adequacy of dialysis.
Blood Urea Nitrogen measurement is used in the diagnosis and treatment of certain
renal and metabolic diseases
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200349 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200349: Stat Profile Prime Plus Analyzer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200349
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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