510(k) · Cleared
ClearedTriage Protein C Controls and Calibration Verification Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · GGN Plasma, Coagulation Control
Cleared on Mar 1, 2007 as substantially equivalent to K000230 (Biosite Incorporated, 2000) and 1 other predicate after a 160-day review. Its family tree reaches back 4 generations to 2000.
- Decided
- Mar 1, 2007
- Review
- 160 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000121 (2000). 5 ancestors in all, the oldest K000230 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK000121 Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array…Beckman Coulter, Inc. · 2000
- 3 generations backK013128 N Latex LP (a)Dade Behring, Inc. · 2002
- 2 generations backK030477 Diadexus Plac TestDiadexus, Inc. · 2003 · Recalled
- 1 generation backK050029 Cardiompo TestPrognostix, Inc. · 2005
- This deviceK062840 Triage Protein C Controls and Calibration Verification ControlsBiosite Incorporated · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000121 | Immage Immunochemistry System Lipoprotein (a) Lpax Reagent, Array System… | Beckman Coulter, Inc. | 2000 | — |
| −3 | K013128 | N Latex LP (a) | Dade Behring, Inc. | 2002 | — |
| −2 | K030477 | Diadexus Plac Test | Diadexus, Inc. | 2003 | 2 |
| −1 | K050029 | Cardiompo Test | Prognostix, Inc. | 2005 | — |
| 0 (this device) | K062840 | Triage Protein C Controls and Calibration Verification Controls | Biosite Incorporated | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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 GGN? 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? (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 |
|---|---|---|---|
| * | K000230 | Triage B-Type Natriuretic Peptide (BNP) ControlsSummary page 1…Unassayed) Product Code: JJX 3. Predicate Devices Triage® BNP (B-Type Natriuretic Peptide) Controls (K000230) PrognostiX CardioMPO~m Control Kit (K050029) 4. Device Description The Triage Protein C Control 1 a… | 2000 |
| * | K050029 | Cardiompo TestSummary page 1…Product Code: JJX 3. Predicate Devices Triage® BNP (B-Type Natriuretic Peptide) Controls (K000230) PrognostiX CardioMPO~m Control Kit (K050029) 4. Device Description The Triage Protein C Control 1 and Control 2, and the Triage Protein C Calibration… | 2005 |
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 7 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K000230.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
MAUDE reports naming product code GGN, 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 | 3 | 47 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 37 |
| 2010 | 3 | 23 | 4 | 17 |
| 2011 | 2 | — | 1 | 30 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 3 | 441 | 3 | 9 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 96 | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 1 | 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 | — | 2 | — |
What is it indicated for?
The Triage Protein C Controls are assayed materials to be used with the Triage Protein C Test to assist the laboratory in monitoring test performance.
The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062840: Triage Protein C Controls and Calibration Verification Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062840
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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