510(k) · Cleared

Cleared

Reference Check, Catalog Number-RCN-10

K013708510(k) TraditionalCleared Dec 10, 200132-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

Precision Biologic · GIZ Plasma, Control, Normal

Cleared on Dec 10, 2001 as substantially equivalent to K001256 (Dade Behring, Inc., 2000) after a 32-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Dec 10, 2001
Review: 32 days
Class: Class II
Product code: GIZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001256 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK001256 Control Plasma NDade Behring, Inc. · 2000
This deviceK013708 Reference Check, Catalog Number-RCN-10Precision Biologic · 2001
Descendant · cites it directly · 0 of its ownK091284 Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and…Affinity Biologicals, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all

K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaAffinity Biologicals, Inc. · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001256	Control Plasma N	Dade Behring, Inc.	2000	—
0 (this device)	K013708	Reference Check, Catalog Number-RCN-10	Precision Biologic	2001	—
+1	K091284	Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal…	Affinity Biologicals, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K013708, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GIZ? 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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K001256	Control Plasma N Summary page 1 …gic.com November 7, 2001 Reference Check Common Name: Normal Control Plasma Classification Name: Plasma, Control, Normal Regutatory Class I, 81 GIZ Control Plasma N (K001256) Dade Behring Inc. Newark, Delaware 19714 USA Reference Check is citrated human plasma collected from 20 or more carefully scre…	Dade Behring, Inc.	2000	—

Also cleared against K001256: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K091284	Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma	Affinity Biologicals, Inc.	2009	0

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?

Its one ancestor has no recall.
Of its descendants, K091284 (Affinity Biologicals, Inc., 2009) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K001256.

How does its category compare?

All GIZ devices

GIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GIZ

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GIZ

Too few GIZ 510(k)s in any year since 2007 to give a median.

Recalls per year · GIZ

1in 2019

2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · GIZ

No MAUDE report names GIZ since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
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	—	0	—

What is it indicated for?

Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays in the normal range. Reference Check is an assayed control for the following parameters in the normal range:

Fibrinogen

Factor il

Factor V

Factor VIi

Factor VIII:C

VvWF: antigen

VWF: Ristocetin Cofactor

Factor IX

Factor X

Factor XI

Factor Xl

Factor Xili

Prekallikrein

Protein C: antigen

Protein C: activity

Protein S: activity

Protein S: total

Protein S: free

Antithrombin: activity

Antithrombin: antigen

Alpha-2-antiplasmin

Plasminogen

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K013708 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013708: Reference Check, Catalog Number-RCN-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013708

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026