510(k) Report

510(k) · Cleared

Cleared

Phenobarbital Enzyme Immunoassay

K946210510(k) TraditionalCleared Feb 10, 199551-day reviewClass II21 CFR 862.3660

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

Diagnostic Reagents, Inc. · DLZ Enzyme Immunoassay, Phenobarbital

Cleared on Feb 10, 1995 after a 51-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
Feb 10, 1995
Review
51 days
Class
Class II
Product code
DLZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1995200020052010201520202025
  1. This deviceK946210 Phenobarbital Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK973536 Ace Phenobarbital Reagent/Aed CalibratorsSchiapparelli Biosystems, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K973536Ace Phenobarbital 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)K946210Phenobarbital Enzyme ImmunoassayDiagnostic Reagents, Inc.1995—
+1K973536Ace Phenobarbital Reagent/Aed CalibratorsSchiapparelli Biosystems, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K946210, 1995–1997Source: 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 DLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DLZ device

  1. #1 K210858 VITROS Chemistry Products PHBR Slidesscore 2.1 · 2 generations · no Class I recall
Get a 510(k) Report

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
K973536Ace Phenobarbital 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, K973536 (Schiapparelli Biosystems, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DLZ devices

DLZ Enzyme Immunoassay, Phenobarbital: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DLZ

1in 2021

2007: 12008: 12013: 12021: 1
2007high 1 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DLZ

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

Recalls per year · DLZ

2in 2013

2009: 12011: 12012: 22013: 2
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · DLZ

1in 2024

2007: 32011: 582012: 2222013: 1012023: 72024: 1
2007high 222 (2012) · low 0 (2008)2025

MAUDE reports naming product code DLZ, 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
20071—03
20081—00
20090—10
20100—00
20110—158
20120—2222
20131—2101
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20211—00
20220—00
20230—07
20240—01
20250—00
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 DLZ

The DLZ category page

  • K210858VITROS Chemistry Products PHBR SlidesOrtho-Clinical Diagnostics, Inc. · 2021
  • K123271Abbott Phenobarbital AssayMicrogenics Corp. · 2013
  • K081231Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33, 1P33Abbott Laboratories · 2008
  • K071644Online Phenobarbital, Model 03016757190 & 03510620Roche Diagnostics Corp. · 2007
  • K011303Randox PhenobarbitalRandox Laboratories, Ltd. · 2001

https://510kreport.com/device/K946210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K946210: Phenobarbital Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946210

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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