510(k) Report

510(k) · Cleared

Cleared

Modified Accufluor Vancomycin Reagent & Calibrator

K900708510(k) TraditionalCleared Apr 19, 199066-day reviewClass II21 CFR 862.3950

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

Innotron of Oregon, Inc. · LEH Radioimmunoassay, Vancomycin

Cleared on Apr 19, 1990 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 19, 1990
Review
66 days
Class
Class II
Product code
LEH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K900708Source: 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 LEH? 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 LEH device

  1. #1 K222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH…score 7.0 · 5 generations · 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?

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 LEH devices

LEH Radioimmunoassay, Vancomycin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LEH

1in 2023

2008: 12013: 12016: 22023: 1
2007high 2 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LEH

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

Recalls per year · LEH

2in 2019

2007: 22019: 2
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · LEH

14in 2025

2007: 42008: 122009: 252010: 482011: 552012: 802013: 732014: 402015: 262016: 102017: 152018: 172019: 132020: 142021: 112022: 72023: 112024: 142025: 14
2007high 80 (2012) · low 4 (2007)2025

MAUDE reports naming product code LEH, 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—24
20081—012
20090—025
20100—048
20110—055
20120—080
20131—073
20140—040
20150—026
20162—010
20170—015
20180—017
20190—213
20200—014
20210—011
20220—07
20231—011
20240—014
20250—014
20260—0—

More from Innotron of Oregon, Inc.

28 FDA decisions under this applicant name. See the company

  • K903101Innofluor (TM) Amikacin Calibrator SetInnotron of Oregon, Inc. · 1990
  • K903100Innofluor (TM) Amikacin Reagent SetInnotron of Oregon, Inc. · 1990
  • K900707Modified Accufluor Tobramycin Reagent & CalibratorInnotron of Oregon, Inc. · 1990
  • K900704Modified Accufluor Phenobarbital Reagent & CalibraInnotron of Oregon, Inc. · 1990
  • K900705Modified Accufluor Quinidine Reagent & CalibratorInnotron of Oregon, Inc. · 1990

Recent decisions in LEH

The LEH category page

  • K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
  • K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)Siemens Healthcare Diagnostics, Inc. · 2016
  • K152245ONLINE TDM Vancomycin Gen.3Roche Diagnostics Operations (Rdo) · 20162 recalls
  • K123947Architect IvancomycinBiokit, S.A. · 2013
  • K072036Architect Ivancomycin Reagents and Architect Ivancomycin Calibrators, Models: 1P30-25 and 1P30-01Biokit, S.A. · 20081 recall

https://510kreport.com/device/K900708 · printed Nov 4, 2026

Cite this page

510(k) Report. “K900708: Modified Accufluor Vancomycin Reagent & Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K900708

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