510(k) Report

510(k) · Cleared

Cleared

Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5

K993755510(k) AbbreviatedCleared Dec 21, 199946-day reviewClass II21 CFR 862.3200

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

Syva Co. · DKB Calibrators, Drug Mixture

Cleared on Dec 21, 1999 after a 46-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
Dec 21, 1999
Review
46 days
Class
Class II
Product code
DKB
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2005: 1 descendant cleared2016: 2 descendants cleared2013: 1 descendant cleared2015: 2 descendants cleared2014: 1 descendant cleared1995200020052010201520202025
  1. This deviceK993755 Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4…Syva Co. · 1999
  2. Descendant · cites it directly · 6 of its ownK051088 Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK153693 Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2016
  4. Descendant · 2 generations on · 0 of its ownK151771 Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis…Immunalysis Corporation · 2016
  5. Descendant · 2 generations on · 0 of its ownK152176 Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug…Immunalysis Corporation · 2015
  6. Descendant · 2 generations on · 0 of its ownK143502 Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates…Immunalysis Corporation · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12013: 12014: 12015: 22016: 2
2005high 2 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 8 · See all
  • K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005 · cites it directly6descendants
  • K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016 · 2 generations on0descendants
  • K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2016 · 2 generations on0descendants
  • K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2015 · 2 generations on0descendants
  • K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300…Immunalysis Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993755Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5Syva Co.1999—
+1K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.20053
+2K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug…Immunalysis Corporation2016—
+2K151771Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug…Immunalysis Corporation2016—
+2K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation2015—
+2K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine…Immunalysis Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201310
201410
201520
201620
FIG. 1 — Lineage of K993755, 1999–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DKB? 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Emit Calibrator Level 0
Named without a submission number
—
*—Emit Calibrators A Level 1 and 2
Named without a submission number
—
*—Emit Calibrators B Level 1 and 2
Named without a submission number
—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K051088Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc.20056
K062162Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)Dade Behring, Inc.20060

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, K051088 (Lin-Zhi International, Inc., 2005) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKB

2in 2014

2009: 22011: 22012: 12014: 2
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

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

Recalls per year · DKB

2in 2022

2009: 32011: 22012: 12022: 2
2007high 3 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DKB

1in 2017

2011: 12012: 42017: 1
2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, 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—00
20080—00
20092—30
20100—00
20112—21
20121—14
20130—00
20142—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—20
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Emit Calibrator/Controls are used in the calibration of the Emit Il Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit Calibrator/Controls are used for the Emit Il Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Mononclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays.

Note:The above listed assays are currently in the process of being filed for 510(k) clearance.

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

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 DKB

The DKB category page

  • K141928Cobas C Acetaminophen Gen.2 Assay, ACET2 CalibratorRoche Diagnostics Operations (Rdo) · 2014
  • K133710Lzi Multiple Analyte Set a;B;C Drugs of Abuse ControlsLin-Zhi International, Inc. · 2014
  • K120936Abbott TDM Multiconstituent Calibrator, Thermo Scientific QMS Multi-Constituent CalibratorsMicrogenics Corporation · 2012
  • K092266Randox Methamphetamine AssayRandox Laboratories, Ltd. · 2011
  • K101752Thermo Scientific Cedia Multi-Drug Oft CalibratorsMicrogenics Corp. · 2011

https://510kreport.com/device/K993755 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993755: Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993755

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026