510(k) · Cleared
ClearedBiophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hyphen Biomed · GGN Plasma, Coagulation Control
Cleared on Mar 17, 2005 as substantially equivalent to K001256 (Dade Behring, Inc., 2000) and 1 other predicate after a 93-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 17, 2005
- Review
- 93 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K941737 (1994). 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 | K941737 | Specialty Assayed Control-1 | Helena Laboratories | 1994 | — |
| −1 | K020878 | Lyphochek Hemostasis, Models 798, 799 | Bio-Rad | 2002 | — |
| 0 (this device) | K043451 | Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator | Hyphen Biomed | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K001256 | Control Plasma NSummary page 2…Biophen Abnormal Control Plasma Classification Name: Plasma Controls, Normal and Abnormal Regulation#: 864.5425 Predicate Device Information: Plasma Control N (K001256) for Biophen Normal Control Plasma Lyphochek® Hemostasis Control (K020878) for Biophen Abnormal Control Plasma Description of… | 2000 |
| * | K020878 | Lyphochek Hemostasis, Models 798, 799Summary page 2…ormal and Abnormal Regulation#: 864.5425 Predicate Device Information: Plasma Control N (K001256) for Biophen Normal Control Plasma Lyphochek® Hemostasis Control (K020878) for Biophen Abnormal Control Plasma Description of the Device/intended use: Biophen Normal and Abnormal Control Plasma is a… | 2002 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K001256.
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?
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay methods for coagulation factors Antithrombin III and Protein C. The following table shows various parameters which are measured using the assays from Hyphen BioMed or from other manufacturers as per the instructions in the package insert. The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.…
Read the full statement (198 words)
Biophen Plasma Calibrator is normal citrated human plasma used as the calibrator in the assay methods for coagulation factors Antithrombin III and Protein C.
The following table shows various parameters which are measured using the assays from Hyphen BioMed or from other manufacturers as per the instructions in the package insert.
The Biophen Plasma Calibrator is tested for the absence of Lupus Anticoagulant and can be used for this investigation.
Biophen Normal and Abnormal Control Plasma is a set of 12 vials each of normal citrated human plasma used as quality control of some coagulation factors.
The following table shows the various parameters which are measured using assays from Hyphen Biomed or from other manufacturers, and as per the package inserts.
DWtest, DWconfirm are registered trade marks from American Diagnostica Inc.
The Biophen Normal and Abnormal Control Plasma are tested for the absence of Lupus Anticoagulant and can be used as a negative control for this investigation.
This control plasma is also tested for the absence of Activated Protein C resistance (Act PC-r). When the APTT is performed with or without Activated Protein C (APC), the ratio obtained (APTT + APC/APTT) is ≥2.00 for the Normal Control Plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043451: Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043451
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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