510(k) Report

510(k) · Cleared

Cleared

Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO. 202-a

K933934510(k) TraditionalCleared Jun 29, 1995687-day reviewClass II21 CFR 864.7360

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

Sigma Diagnostics, Inc. · JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Cleared on Jun 29, 1995 after a 687-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 29, 1995
Review
687 days
Class
Class II
Product code
JBF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2016: 1 descendant cleared1995200020052010201520202025
  1. This deviceK933934 Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO.…Sigma Diagnostics, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK080003 Binaxnow G6PD TestBinax, Inc. · 2008
  3. Descendant · 2 generations on · 0 of its ownK161364 BinaxNOW G6PD TestAlere Scarborough, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K080003Binaxnow G6PD TestBinax, Inc. · 2008 · cites it directly1descendant
  • K161364BinaxNOW G6PD TestAlere Scarborough, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933934Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO. 202-aSigma Diagnostics, Inc.1995—
+1K080003Binaxnow G6PD TestBinax, Inc.2008—
+2K161364BinaxNOW G6PD TestAlere Scarborough, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201610
FIG. 1 — Lineage of K933934, 1995–2016Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JBF? 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 JBF device

  1. #1 K201049 Finder G6PDscore 4.0 · 1 generation · no Class I recall
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K080003Binaxnow G6PD TestBinax, Inc.20081

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, K080003 (Binax, Inc., 2008) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JBF devices

JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JBF

1in 2022

2008: 12016: 12022: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JBF

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

Recalls per year · JBF

No recall names JBF since 2007.

Adverse event reports per year · JBF

4in 2023

2019: 12020: 12021: 12023: 4
2007high 4 (2023) · low 0 (2007)2025

MAUDE reports naming product code JBF, 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
20081—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—01
20200—01
20210—01
20221—00
20230—04
20240—00
20250—00
20260—0—

More from Sigma Diagnostics, Inc.

164 FDA decisions under this applicant name. See the company

  • K021162Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation…Sigma Diagnostics, Inc. · 2002
  • K020109Sigma Diagnostics Accuclot LA ControlSigma Diagnostics, Inc. · 2002
  • K013549Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971Sigma Diagnostics, Inc. · 2001
  • K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001
  • K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc. · 2001

Recent decisions in JBF

The JBF category page

  • K201049Finder G6PDBaebies, Inc. · 2022
  • K161364BinaxNOW G6PD TestAlere Scarborough, Inc. · 2016
  • K080003Binaxnow G6PD TestBinax, Inc. · 2008
  • K024006G6PDH, Glucose-6-Phoshate DehydrogenasePointe Scientific, Inc., · 20031 recall

https://510kreport.com/device/K933934 · printed Nov 5, 2026

Cite this page

510(k) Report. “K933934: Glucose-6-Phosphate Dehydrogenase Deficiency Screening Test Kit NO. 202-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933934

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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