510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)

K943780510(k) TraditionalCleared Oct 31, 199489-day reviewClass I21 CFR 862.1660Recalls 7

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

Heraeus Kulzer, Inc. · JJW Urinalysis Controls (Assayed And Unassayed)

Cleared on Oct 31, 1994 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 7 times.

Decided
Oct 31, 1994
Review
89 days
Class
Class I
Product code
JJW
Recalls
7
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K943780Source: FDA 510(k) database · 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 JJW? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Nov 21, 2012Class IIIZ-0637-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Nov 21, 2012Class IIIZ-0639-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Nov 21, 2012Class IIZ-0640-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Nov 21, 2012Class IIIZ-0641-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Nov 21, 2012Class IIIZ-0635-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Nov 21, 2012Class IIIZ-0636-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
Nov 21, 2012Class IIIZ-0638-2013Nonconforming Material/ComponentWhen these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JJW devices

JJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJW

1in 2017

2007: 22009: 12011: 22014: 12015: 12017: 1
2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJW

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

Recalls per year · JJW

2in 2024

2007: 12012: 72013: 12022: 22024: 2
2007high 7 (2012) · low 0 (2008)2026

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

Adverse event reports per year · JJW

1in 2022

2007: 22009: 12012: 12013: 242022: 1
2007high 24 (2013) · low 0 (2008)2025

MAUDE reports naming product code JJW, 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
20072—12
20080—00
20091—01
20100—00
20112—00
20120—71
20130—124
20141—00
20151—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—21
20230—00
20240—20
20250—00
20260—0—

More from Heraeus Kulzer, Inc.

145 FDA decisions under this applicant name. See the company

  • K091494Flexitime FlowHeraeus Kulzer, Inc. · 2009
  • K063062Hkbond 2006Heraeus Kulzer, Inc. · 2006
  • K060994MondialHeraeus Kulzer, Inc. · 2006
  • K052543Heraceram ZirkoniaHeraeus Kulzer, Inc. · 2005
  • K043504PalaimpactHeraeus Kulzer, Inc. · 2005

Recent decisions in JJW

The JJW category page

  • K170091UA-Cellular CompleteStreck · 2017
  • K142262Aution Check PlusQuantimetrix Corp. · 2015
  • K131444UA-Cellular CompleteStreck · 2014
  • K110846Randox Urinalysis Controls, Levels 1 and 2Randox Laboratories Limited · 20111 recall
  • K103387Mission Liquid Urine Control, Mission Liquid Diptube Urine Control, Mission Dry Strip Urine ControlACON Laboratories, Inc. · 2011

https://510kreport.com/device/K943780 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943780: Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943780

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