510(k) Report

510(k) · Cleared

Cleared

Quantex Aso Plus (Latex,Buffer Standard,Control)

K894486510(k) TraditionalCleared Oct 24, 198998-day reviewClass I21 CFR 866.3720

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

Biokit USA, Inc. · GTQ Antistreptolysin - Titer/Streptolysin O Reagent

Cleared on Oct 24, 1989 after a 98-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
Oct 24, 1989
Review
98 days
Class
Class I
Product code
GTQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared1990200020102020
  1. This deviceK894486 Quantex Aso Plus (Latex,Buffer Standard,Control)Biokit USA, Inc. · 1989
  2. Descendant · cites it directly · 1 of its ownK971777 Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO · 1997
  3. Descendant · 2 generations on · 0 of its ownK984437 Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K971777Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO · 1997 · cites it directly1descendant
  • K984437Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K894486Quantex Aso Plus (Latex,Buffer Standard,Control)Biokit USA, Inc.1989—
+1K971777Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO1997—
+2K984437Quantex Aso-CRP-RP Control IIInstrumentation Laboratory CO1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
FIG. 1 — Lineage of K894486, 1989–1999Source: 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 GTQ? 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K971777Quantex Aso-CRP-RF ControlInstrumentation Laboratory CO19971

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, K971777 (Instrumentation Laboratory CO, 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GTQ devices

GTQ Antistreptolysin - Titer/Streptolysin O Reagent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GTQ

FDA has decided no GTQ device since 2007.

Median 510(k) review, days · GTQ

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

Recalls per year · GTQ

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

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

Adverse event reports per year · GTQ

1in 2025

2011: 12017: 12024: 12025: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code GTQ, 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—10
20080—10
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—01
20250—01
20260—0—

More from Biokit USA, Inc.

16 FDA decisions under this applicant name. See the company

  • K913467ToxogenBiokit USA, Inc. · 1993
  • K910541Biokit RPRBiokit USA, Inc. · 1991
  • K904310Rheumagen RF T-ControlBiokit USA, Inc. · 1991
  • K910539Rheumajet RFBiokit USA, Inc. · 1991
  • K910686Rheumajet CRPBiokit USA, Inc. · 1991

Recent decisions in GTQ

The GTQ category page

  • K052645Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref…Ortho-Clinical Diagnostics · 2005
  • K953437Olympus Anti-Sterptolysin O Immunoturbidimetric ReagentOlympus America, Inc. · 1995
  • K915742Turbiquant AslBehring Diagnostics, Inc. · 1993
  • K926236Beckman Anti-Streptolysin O KitBeckman Instruments, Inc. · 19931 recall
  • K924247Accutex Aso Latex TestJ.S. Medical Assoc. · 1992

https://510kreport.com/device/K894486 · printed Nov 6, 2026

Cite this page

510(k) Report. “K894486: Quantex Aso Plus (Latex,Buffer Standard,Control).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894486

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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