510(k) Report

510(k) · Cleared

Cleared

Pathfinder (TM) Chlamydia Microplate Kit

K902253510(k) TraditionalCleared Jul 26, 199066-day reviewClass I21 CFR 866.3120

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

Kallestad Diag, A Div. of Erbamont, Inc. · LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Cleared on Jul 26, 1990 after a 66-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 26, 1990
Review
66 days
Class
Class I
Product code
LJC
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K902253Source: 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 LJC? 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?

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 LJC devices

LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJC

FDA has decided no LJC device since 2007.

Median 510(k) review, days · LJC

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

Recalls per year · LJC

1in 2025

2008: 22011: 12025: 1
2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LJC

1in 2019

2018: 22019: 1
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LJC, 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
20080—20
20090—00
20100—00
20110—10
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—02
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—10
20260—0—

More from Kallestad Diag, A Div. of Erbamont, Inc.

58 FDA decisions under this applicant name. See the company

  • K910885QM300 Calibrator G PackKallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K910886QM300 Antistreptolysin O (Aso) Antigen PackKallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K910887QM300 Control G PackKallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K904725Chlamydia System Software (CSS)Kallestad Diag, A Div. of Erbamont, Inc. · 1991
  • K902462Modified QM300 Rheumatoid Factor TestKallestad Diag, A Div. of Erbamont, Inc. · 1990

Recent decisions in LJC

The LJC category page

  • K032330CT OIAThermo Biostar, Inc. · 2004
  • K033865Ideia Pce ChlamydiaDakocytomation, Ltd. · 2004
  • K033079Chlamydia Igg Elisa Test SystemTrinity Biotech USA · 2003
  • K982210Modification of Syva Microtrak II Chlamydia EiaDade Behring, Inc. · 1998
  • K962558Chlamydia Igg Elisa Test SystemArmkel, LLC · 1997

https://510kreport.com/device/K902253 · printed Nov 4, 2026

Cite this page

510(k) Report. “K902253: Pathfinder (TM) Chlamydia Microplate Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K902253

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