510(k) Report

510(k) · Cleared

Cleared

Polychaco Fia-Abs Test for Syphilis

K831296510(k) TraditionalCleared Jul 26, 198397-day reviewClass II21 CFR 866.3830

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

Parasitic Disease Consultants · JWL Antigen, Treponema Pallidum For Fta-Abs Test

Cleared on Jul 26, 1983 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 26, 1983
Review
97 days
Class
Class II
Product code
JWL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831296Source: 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 JWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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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 JWL devices

JWL Antigen, Treponema Pallidum For Fta-Abs Test: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWL

FDA has decided no JWL device since 2007.

Median 510(k) review, days · JWL

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

Recalls per year · JWL

No recall names JWL since 2007.

Adverse event reports per year · JWL

1in 2013

2011: 12013: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code JWL, 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—00
20090—00
20100—00
20110—01
20120—00
20130—01
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—

More from Parasitic Disease Consultants

3 FDA decisions under this applicant name. See the company

  • K830870Polychaco Indirect HemagglutinationParasitic Disease Consultants · 1983
  • K830869Polychaco Indirect ImmunofluorescenceParasitic Disease Consultants · 1983

Recent decisions in JWL

The JWL category page

  • K801959Fta-Abs TestImmuno-Diagnostic Products, Inc. · 1980
  • K802276Fta-Abs BiopakBioware Products · 1980
  • K801928Lab-Tek Fta-Abs KitMiles Laboratories, Inc. · 1980

https://510kreport.com/device/K831296 · printed Nov 6, 2026

Cite this page

510(k) Report. “K831296: Polychaco Fia-Abs Test for Syphilis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831296

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