510(k) Report

510(k) · Cleared

Cleared

Valproic Acid Eia Test

K961988510(k) TraditionalCleared Jul 16, 199656-day reviewClass II21 CFR 862.3645

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

Diagnostic Reagents, Inc. · LEG Enzyme Immunoassay, Valproic Acid

Cleared on Jul 16, 1996 after a 56-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Jul 16, 1996
Review
56 days
Class
Class II
Product code
LEG
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK961988 Valproic Acid Eia TestDiagnostic Reagents, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK973581 Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K973581Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K961988Valproic Acid Eia TestDiagnostic Reagents, Inc.1996—
+1K973581Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K961988, 1996–1997Source: 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 LEG? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K973581Ace Valproic Acid Reagent, Aed CalibratorsSchiapparelli Biosystems, Inc.19970

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, K973581 (Schiapparelli Biosystems, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LEG devices

LEG Enzyme Immunoassay, Valproic Acid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LEG

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LEG

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

Recalls per year · LEG

1in 2018

2007: 12011: 12018: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LEG

5in 2025

2007: 122008: 382009: 182010: 132011: 382012: 292013: 292014: 202015: 32016: 252017: 82018: 242019: 132020: 92021: 122022: 192023: 12024: 142025: 5
2007high 38 (2008) · low 1 (2023)2025

MAUDE reports naming product code LEG, 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
20070—112
20080—038
20091—018
20100—013
20110—138
20120—029
20130—029
20140—020
20150—03
20160—025
20170—08
20180—124
20190—013
20200—09
20210—012
20220—019
20230—01
20240—014
20250—05
20260—0—

More from Diagnostic Reagents, Inc.

66 FDA decisions under this applicant name. See the company

  • K983268Modification of Tricyclic Serum Tox Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983812Napa Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983323Digoxin ImmunoassayDiagnostic Reagents, Inc. · 1998
  • K983280Vancomycin Eia AssayDiagnostic Reagents, Inc. · 1998
  • K983159Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998

Recent decisions in LEG

The LEG category page

  • K090358Architect Ivalproic Acid Reagents and Architect Ivalproic Acid Calibrators, Models 1P35, 1P35Abbott Laboratories, Inc. · 2009
  • K060690Online Valproic AcidRoche Diagnostics Corp. · 20061 recall
  • K042807Advia Ims Valproic Acid MethodBayer Healthcare, LLC · 2005
  • K042476Vitros Chemistry Products Valp Reagent; Vitro Chemistry Products Calibrator Kit 12; Vitros Chemistry…Ortho-Clinical Diagnostics, Inc. · 20043 recalls
  • K032049Roche Online TDM Valproic AcidRoche Diagnostics Corp. · 2003

https://510kreport.com/device/K961988 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961988: Valproic Acid Eia Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961988

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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