510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Emit (R) 2000 Phenobarbital Assay/Calibrators

K913190510(k) TraditionalCleared Aug 26, 199139-day reviewClass II21 CFR 862.3660Recalls 3

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

Syva Co. · DLZ Enzyme Immunoassay, Phenobarbital

Cleared on Aug 26, 1991 after a 39-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. It has been recalled 3 times.

Decided
Aug 26, 1991
Review
39 days
Class
Class II
Product code
DLZ
Recalls
3
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK913190 Emit (R) 2000 Phenobarbital Assay/CalibratorsSyva Co. · 1991
  2. Descendant · cites it directly · 1 of its ownK993031 Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and…Syva Co. · 2000 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK123271 Abbott Phenobarbital AssayMicrogenics Corp. · 2013

Most influential descendants

Showing 2 of 2 · See all
  • K993031Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54Syva Co. · 2000 · cites it directly1descendant
  • K123271Abbott Phenobarbital AssayMicrogenics Corp. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K913190Emit (R) 2000 Phenobarbital Assay/CalibratorsSyva Co.1991—
+1K993031Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54Syva Co.20002
+2K123271Abbott Phenobarbital AssayMicrogenics Corp.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
201310
FIG. 1 — Lineage of K913190, 1991–2013Source: 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K993031Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54Syva Co.20001

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 30, 2013Class IIZ-0181-2014Nonconforming Material/ComponentImprecision with certain lots
Dec 10, 2012Class IIZ-0664-2013Nonconforming Material/ComponentFirm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be…
Jul 30, 2012Class IIZ-0030-2013Nonconforming Material/ComponentFirm has confirmed highter imprecision with the recalled lots on Beckman Coulter AU(R) Systems. Also, if the Syva(R) Emit(R) 2000 Phenobartbital Assay (4D019UL) lots D4, D5, D6, and/or D7 as an application on AU(R) Systems is used, the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K993031 (Syva Co., 2000) has gone furthest, with 1 descendant 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 Syva Co.

448 FDA decisions under this applicant name. See the company

  • K011878Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109ULSyva Co. · 2001
  • K012257Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229Syva Co. · 2001
  • K011947Emit 2000 Valproic Acid Assay, Model OSR4G229ULSyva Co. · 2001
  • K011528Emit 2000 Phenobarbital Assay, Model OSR4D229Syva Co. · 20013 recalls
  • K011347Emit 2000 Phenytoin Assay, Model 0SR4A229Syva Co. · 2001

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/K913190 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913190: Emit (R) 2000 Phenobarbital Assay/Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913190

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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