510(k) Report

510(k) · Cleared

Recalled · 2003

Chlamydia Oia

K951010510(k) TraditionalCleared Oct 7, 1995215-day reviewClass I21 CFR 866.3120Recalls 2

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

Biostar, Inc. · LJC Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Cleared on Oct 7, 1995 after a 215-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided
Oct 7, 1995
Review
215 days
Class
Class I
Product code
LJC
Recalls
2
Predicates
0

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

Descendants, by year cleared 2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951010 Chlamydia OiaBiostar, Inc. · 1995
  2. Descendant · cites it directly · 0 of its ownK023947 GC OIAThermo Biostar, Inc. · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K023947GC OIAThermo Biostar, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951010Chlamydia OiaBiostar, Inc.1995—
+1K023947GC OIAThermo Biostar, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K951010, 1995–2003Source: 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 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 lists a 510(k) statement for it but has not posted the file, 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
K023947GC OIAThermo Biostar, Inc.20030

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 7, 2003Not classifiedZ-0616-03OtherChlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
Feb 7, 2003Not classifiedZ-0615-03OtherChlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K023947 (Thermo Biostar, Inc., 2003) has gone furthest, with 0 descendants of its own.

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 Biostar, Inc.

6 FDA decisions under this applicant name. See the company

  • K991829Cdtox a OiaBiostar, Inc. · 1999
  • K991828Strep B OiaBiostar, Inc. · 1999
  • K981651AB Flu OiaBiostar, Inc. · 1998
  • K962060Strep a Oia MaxBiostar, Inc. · 19971 recall
  • K936112Strep B OiaBiostar, Inc. · 1994

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/K951010 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951010: Chlamydia Oia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951010

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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