510(k) Report

510(k) · Cleared

Cleared

Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma

K091284510(k) TraditionalCleared Oct 28, 2009180-day reviewClass II21 CFR 864.5425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Affinity Biologicals, Inc. · GGN Plasma, Coagulation Control

Cleared on Oct 28, 2009 as substantially equivalent to K952622 (Precision Biologicals, Inc., 1995) and 3 other predicates after a 180-day review. Its family tree reaches back 2 generations to 2000.

Decided
Oct 28, 2009
Review
180 days
Class
Class II
Product code
GGN
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K001256 (2000). 6 ancestors in all, the oldest K924393 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor1995: 2 other ancestors1992: 1 other ancestorK001256 · Control Plasma N · Dade Behring, Inc. · 2000K013708 · Reference Check, Catalog Number-RCN-10 · Precision Biologic · 200119901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K013708 · Reference Check, Catalog Number-RCN-10 · Precision Biologic · 2001K001256 · Control Plasma N · Dade Behring, Inc. · 20000
  1. Root · 2 generations backK001256 Control Plasma NDade Behring, Inc. · 2000
  2. 1 generation backK013708 Reference Check, Catalog Number-RCN-10Precision Biologic · 2001
  3. This deviceK091284 Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and…Affinity Biologicals, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001256Control Plasma NDade Behring, Inc.2000—
−1K013708Reference Check, Catalog Number-RCN-10Precision Biologic2001—
0 (this device)K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal…Affinity Biologicals, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199520
200310
FIG. 1 — Lineage of K091284, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K952622Cryo Check Normal Human Reference Plasma
Summary page 1
…Subpart H, Hematology Kits and Packages Product Code: GGN Predicate Devices: Cryocheck Normal Reference Plasma, K952622 Precision Biologic and Standar…
Precision Biologicals, Inc.1995—
*K023141Modification to Standard Human Plasma
Summary page 1
…eference Plasma, K952622 Precision Biologic and Standard Human Plasma, K023141 Dade Behring Inc. Device Description: The VisuCal-F Frozen Calibrator Plasma is a…
Dade Behring, Inc.2003—
*K013708Reference Check, Catalog Number-RCN-10
Summary page 3
…Subpart H,Hematology Kits and Packages Product Code: GGN Predicate Device: Reference Control Normal (Reference Check), K013708 Precision Biologic Device Description: The VisuCon-F Frozen Normal Control Plasma i…
Precision Biologic2001—
*K952624Cryo Check Abnormal Reference Check I & II
Summary page 5
…Subpart H, Hematology Kits and Packages Product Code: GGN Predicate Device: Cryocheck Abnormal 1 Reference Control, K952624 Precision Biologic Device Description: The VisuCon-F Frozen Abnormal Control Plasma…
Precision Biologicals, Inc.1995—

Also cleared against K952622: 1 other device →

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 6 ancestors has a recall.
  • 1 other device also cites its predicate K952622.

How does its category compare?

All GGN devices

GGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GGN

4in 2017

2007: 32008: 12009: 22010: 32011: 22012: 12013: 32014: 22016: 22017: 4
2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007: 47 days median2010: 23 days median2013: 441 days median2017: 96 days median
2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2010: 42011: 12013: 32019: 12026 (partial year): 2
2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGN

4in 2018

2009: 372010: 172011: 302012: 102013: 92014: 52015: 102016: 92017: 112018: 4
2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200734700
20081—00
20092—037
2010323417
20112—130
20121—010
2013344139
20142—05
20150—010
20162—09
2017496011
20180—04
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—2—

What is it indicated for?

The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coagulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX,X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor. The VisuCon-F Frozen Abnormal Control plasma is…

Read the full statement (147 words)

The VisuCal-F Frozen Calibrator plasma is intended for use in the calibration of coagulation and fibrinolysis assays including the following: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX,X, XI, XII, antithrombin activity, alpha-2-antiplasmin, plasminogen, Protein C activity and antigen, Protein S activity and total antigen and von Willebrand factor antigen and Ristocetin Cofactor.

The VisuCon-F Frozen Abnormal Control plasma is intended for use in the quality control of coagulation assays in the borderline pathological range for the following parameters: fibrinogen (Clauss Method), coagulation factors II,V, VII, VIII, IX,X, XI, XII, antithrombin activity, Protein C activity and Protein S activity.

The VisuCon-F Frozen Normal Control plasma is intended for use in the quality control of coagulation assays in the normal range for the following parameters: fibrinogen (Clauss Method), coagulation factors II, V, VII, VIII, IX,X, Xi, XII, antithrombin activity, Protein C activity and Protein S activity.

Indications for use as stated in the FDA summary.

Also cleared against K952622

1 other device cites the same predicate.

  • K022046Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag Coagulation ControlVital Scientific N.V. · 2002

More from Affinity Biologicals, Inc.

5 FDA decisions under this applicant name. See the company

  • K150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, Inc. · 2016
  • K110432Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnAffinity Biologicals, Inc. · 2011
  • K052825Visulize Factor Viii Antigen Kit, Model Fviii-AGAffinity Biologicals, Inc. · 2006
  • K051054Visulize Factor IX Antigen KitAffinity Biologicals, Inc. · 2005

Recent decisions in GGN

The GGN category page

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https://510kreport.com/device/K091284 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091284: Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal 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/K091284

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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