510(k) Report

510(k) · Cleared

Cleared

Rubella Elisa Test System

K891783510(k) TraditionalCleared Aug 3, 1989132-day reviewClass II21 CFR 866.3510

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

Zeus Scientific, Inc. · LFX Enzyme Linked Immunoabsorbent Assay, Rubella

Cleared on Aug 3, 1989 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Aug 3, 1989
Review
132 days
Class
Class II
Product code
LFX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared1990200020102020
  1. This deviceK891783 Rubella Elisa Test SystemZeus Scientific, Inc. · 1989
  2. Descendant · cites it directly · 0 of its ownK093784 Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891783Rubella Elisa Test SystemZeus Scientific, Inc.1989—
+1K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K891783, 1989–2010Source: 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 LFX? 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 LFX device

  1. #1 K250588 Access Rubella IgGscore 10.4 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
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? (1)

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

NumberDeviceApplicantDecidedDescendants
K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc.20100

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, K093784 (Zeus Scientific, Inc., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LFX devices

LFX Enzyme Linked Immunoabsorbent Assay, Rubella: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFX

2in 2025

2007: 12008: 32010: 22011: 12012: 12025: 2
2007high 3 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFX

354in 2008

2008: 354 days median
2007high 354 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LFX

1in 2021

2007: 22008: 22009: 32010: 22011: 12016: 22021: 1
2007high 3 (2009) · low 0 (2012)2026

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

Adverse event reports per year · LFX

12in 2025

2007: 52008: 3672009: 192010: 182011: 892012: 372013: 152014: 132015: 152016: 472017: 102018: 242019: 162020: 212021: 132022: 132023: 72024: 132025: 12
2007high 367 (2008) · low 5 (2007)2025

MAUDE reports naming product code LFX, 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
20071—25
200833542367
20090—319
20102—218
20111—189
20121—037
20130—015
20140—013
20150—015
20160—247
20170—010
20180—024
20190—016
20200—021
20210—113
20220—013
20230—07
20240—013
20252—012
20260—0—

More from Zeus Scientific, Inc.

140 FDA decisions under this applicant name. See the company

  • K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc. · 2022
  • K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemZeus Scientific, Inc. · 2019
  • K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemZeus Scientific, Inc. · 2019
  • K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemZeus Scientific, Inc. · 2019
  • P150045Zeus Elisa Parvovirus B19 Igg Test SystemZeus Scientific, Inc. · 20171 recall

Recent decisions in LFX

The LFX category page

  • K250588Access Rubella IgGBeckman Coulter, Inc. · 2025
  • K243168Alinity i Rubella IgGAbbott Laboratories · 2025
  • K122397Liaison Rubella Igm, Liaison Control Rubella IgmDiaSorin, Inc. · 2012
  • K093101MAGO 4SDiamedix Corp. · 2011
  • K092587Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemBio-Rad Laboratories · 2010

https://510kreport.com/device/K891783 · printed Nov 3, 2026

Cite this page

510(k) Report. “K891783: Rubella Elisa Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K891783

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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