510(k) · Cleared
ClearedControl Plasma N, Proc Control Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GGN Plasma, Coagulation Control
Cleared on Dec 1, 2004 as substantially equivalent to K023309 (Dade Behring, Inc., 2002) and 1 other predicate after a 93-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 1, 2004
- Review
- 93 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945940 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945940 | Coatest (R) Apc (TM) Resistance | Axis-Shield Doc AS | 1995 | — |
| −1 | K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S | Chromogenix AB | 1996 | — |
| 0 (this device) | K042333 | Control Plasma N, Proc Control Plasma | Dade Behring, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K023309 | Control Plasma NSummary page 1…Multipurpose system for in vitro coagulation studies, Class 11 (864.5425) 3. Identification of the Legally Marketed Device: Control Plasma N (K023309) and Chromogenix Control Plasma Level 2 (K9631 11) 4. Device Description: Control Plasma N is a Iyophi… | 2002 |
| * | K963111 | Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V SSummary page 1…dies, Class 11 (864.5425) 3. Identification of the Legally Marketed Device: Control Plasma N (K023309) and Chromogenix Control Plasma Level 2 (K9631 11) 4. Device Description: Control Plasma N is a Iyophilized control prepared from pooled human plasma, s… | 1996 |
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 9 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K023309.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range:
1. Prothrombin time (PT)
2. Activated partial thromboplastin time (APTT)
3. Thrombin time (TT)
4. Batroxobin time
5. Fibrinogen
6. Coagulation factors II,V, VII, VIII, vWF, IX, X, XI, XII
7. Inhibitors: Antithrombin III, protein C, protein S, c2 -antiplasmin
8. Plasminogen
9. Lupus anticoagulants
10. Factor V Leiden
ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042333 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042333: Control Plasma N, Proc Control Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042333
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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