510(k) Report

510(k) · Cleared

Cleared

Bioscan Reagent Strips

K943008510(k) TraditionalCleared Aug 8, 199445-day reviewClass I21 CFR 862.1115

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

Genesis Labs, Inc. · JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)

Cleared on Aug 8, 1994 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Aug 8, 1994
Review
45 days
Class
Class I
Product code
JJB
Recalls
None
Predicates
0

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

Descendants, by year cleared 1998: 1 descendant cleared1997: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared1990200020102020
  1. This deviceK943008 Bioscan Reagent StripsGenesis Labs, Inc. · 1994
  2. Descendant · cites it directly · 3 of its ownK971976 Diascreen Reagent StripsDia-Screen Corp. · 1997
  3. Descendant · 2 generations on · 1 of its ownK083184 Tearlab Osmolarity SystemOcusense, Inc. · 2009
  4. Descendant · 3 generations on · 0 of its ownK132066 Inflamma DryRapid Pathogen Screening, Inc. · 2013 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK030650 Stoneguard II Reagent Strips for Urinalysis and Confirm Control…Uridynamics, Inc. · 2003
  6. Descendant · cites it directly · 0 of its ownK981555 Diascreen Reagent StripsChronimed, Inc. · 1998 · Recalled

Most influential descendants

Showing 5 of 5 · See all
  • K971976Diascreen Reagent StripsDia-Screen Corp. · 1997 · cites it directly3descendants
  • K083184Tearlab Osmolarity SystemOcusense, Inc. · 2009 · 2 generations on1descendant
  • K132066Inflamma DryRapid Pathogen Screening, Inc. · 2013 · 3 generations on0descendants
  • K030650Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsUridynamics, Inc. · 2003 · 2 generations on0descendants
  • K981555Diascreen Reagent StripsChronimed, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K943008Bioscan Reagent StripsGenesis Labs, Inc.1994—
+1K971976Diascreen Reagent StripsDia-Screen Corp.1997—
+2K083184Tearlab Osmolarity SystemOcusense, Inc.2009—
+3K132066Inflamma DryRapid Pathogen Screening, Inc.20133
+2K030650Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsUridynamics, Inc.2003—
+1K981555Diascreen Reagent StripsChronimed, Inc.19981

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
200310
200910
201310
FIG. 1 — Lineage of K943008, 1994–2013Source: 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 JJB? 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? (5)

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

NumberDeviceApplicantDecidedDescendants
K971976Diascreen Reagent StripsDia-Screen Corp.19973
K981555Diascreen Reagent StripsChronimed, Inc.19980

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, K971976 (Dia-Screen Corp., 1997) has gone furthest, with 3 descendants of its own.

How does its category compare?

All JJB devices

JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJB

FDA has decided no JJB device since 2007.

Median 510(k) review, days · JJB

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

Recalls per year · JJB

No recall names JJB since 2007.

Adverse event reports per year · JJB

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code JJB, 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—02
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Genesis Labs, Inc.

3 FDA decisions under this applicant name. See the company

  • K961375Dia Screen 10 Way Reagent StripsGenesis Labs, Inc. · 1996
  • K952971Dia Screen Reagent StripsGenesis Labs, Inc. · 1995

Recent decisions in JJB

The JJB category page

  • K943436Urine Reagent Strips-8 ParametersTeco Diagnostics · 1995
  • K873553Wako (TM) Pretest 8AWako Chemicals USA, Inc. · 1987
  • K862806Urine Diagnostic Reagent StripsAmatech International, Inc. · 1986
  • K833521Reagent Tests Strip CombinationsSyn-Kit, Inc. · 1984

https://510kreport.com/device/K943008 · printed Nov 6, 2026

Cite this page

510(k) Report. “K943008: Bioscan Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943008

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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