510(k) Report

510(k) · Cleared

Cleared

Etest for Quinupristin/Dalfopristin

K992993510(k) TraditionalCleared Nov 16, 199970-day reviewClass II21 CFR 866.1620

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

Ab Biodisk · LTX Discs, Elution

Cleared on Nov 16, 1999 after a 70-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Nov 16, 1999
Review
70 days
Class
Class II
Product code
LTX
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K992993Source: FDA 510(k) database · How lineage is built

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Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LTX devices

LTX Discs, Elution: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LTX

FDA has decided no LTX device since 2007.

Median 510(k) review, days · LTX

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

Recalls per year · LTX

No recall names LTX since 2007.

Adverse event reports per year · LTX

No MAUDE report names LTX since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
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—

What is it indicated for?

For In vitro diagnostic use: Etest Is a quantitative technique for the determination of antimicrohial susceptibility ot both non-fastidious Gram negative and Gram positive aerobic bacteria, such as fnterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneurnococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used (0 determine the Minimum Inhibitory…

Read the full statement (105 words)

For In vitro diagnostic use:

Etest Is a quantitative technique for the determination of antimicrohial susceptibility ot both non-fastidious Gram negative and Gram positive aerobic bacteria, such as fnterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, Pneurnococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used (0 determine the Minimum Inhibitory Concentration (MIC) in pg/inl of individual antibiotics against bacteria as tested on agar media by overnight incubdtion.

This Etest 510(k) application is for MIC determination of Quinupristin/Dalfopristin in the range of 0.002 - 32 pg/ml with multi-resistant, including Vancomycin resistant, Enterococcus faecium and Methicillin-susceptible Staphylococcus aureus.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Ab Biodisk

64 FDA decisions under this applicant name. See the company

  • K081325Etest Doripenem - Antimicrobial Susceptibility Test - Mic at 0.002-32 UG/MLAb Biodisk · 20081 recall
  • K052366Etest Tigecycline Gram Positive and Gram Negative Aerobic Bacteria, Streptococcus SPP. and Anaerobic BacteriaAb Biodisk · 2005
  • K042392DaptomycinAb Biodisk · 2004
  • K042390Etest for GemifloxacinAb Biodisk · 2004
  • K040560Etest for Antifungal Suscepttibility TestingAb Biodisk · 20041 recall

Recent decisions in LTX

The LTX category page

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  • N50485/S014Amikacin Elution Disk for AutobacOrganon Teknika Corp. · 1985

https://510kreport.com/device/K992993 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992993: Etest for Quinupristin/Dalfopristin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992993

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