510(k) Report

510(k) · Cleared

Cleared

Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma

K935254510(k) TraditionalCleared Sep 19, 1994322-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

American Diagnostica, Inc. · GIZ Plasma, Control, Normal

Cleared on Sep 19, 1994 after a 322-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Sep 19, 1994
Review
322 days
Class
Class II
Product code
GIZ
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK935254 Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal…American Diagnostica, Inc. · 1994
  2. Descendant · cites it directly · 0 of its ownK102552 Hemosil LA Positive ControlInstrumentation Laboratory CO · 2011
  3. Descendant · cites it directly · 0 of its ownK083878 Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc. · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K102552Hemosil LA Positive ControlInstrumentation Laboratory CO · 2011 · cites it directly0descendants
  • K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935254Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control PlasmaAmerican Diagnostica, Inc.1994—
+1K102552Hemosil LA Positive ControlInstrumentation Laboratory CO2011—
+1K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
FIG. 1 — Lineage of K935254, 1994–2011Source: 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), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102552Hemosil LA Positive ControlInstrumentation Laboratory CO20110
K083878Lupotek Correctin VL, Lupotek Detectin VL, Plasmacon LAR2 Diagnostics, Inc.20100

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?

  • Of its descendants, K102552 (Instrumentation Laboratory CO, 2011) has gone furthest, with 0 descendants of its own.

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

2007: 1
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

2019: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from American Diagnostica, Inc.

10 FDA decisions under this applicant name. See the company

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  • K063323Spectrolyse Pai-1, Model 101201American Diagnostica, Inc. · 20072 recalls
  • K052124Acticlot, Model 824American Diagnostica, Inc. · 20051 recall
  • K013637Actichrome Heparin (Anti-Fiia)American Diagnostica, Inc. · 2002
  • K013492Imubind Tpa Elisa, Model 860American Diagnostica, Inc. · 2002

Recent decisions in GIZ

The GIZ category page

  • K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal…Wortham Laboratories, Inc. · 2007
  • K042941Dade Behring Heparin Calibrator and ControlsDade Behring, Inc. · 2004
  • K023309Control Plasma NDade Behring, Inc. · 2002
  • K013708Reference Check, Catalog Number-RCN-10Precision Biologic · 2001
  • K003328Accuclot Control I, Model A4089Sigma Diagnostics, Inc. · 2001

https://510kreport.com/device/K935254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935254: Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935254

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026