510(k) Report

510(k) · Cleared

Cleared

Adi Syphilis RPR Liquid Controls

K980638510(k) TraditionalCleared Jul 6, 1998137-day reviewClass II21 CFR 866.3820

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

Ampcor Diagnostics, Inc. · GMP Antisera, Control For Nontreponemal Tests

Cleared on Jul 6, 1998 after a 137-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jul 6, 1998
Review
137 days
Class
Class II
Product code
GMP
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K980638Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 GMP devices

GMP Antisera, Control For Nontreponemal Tests: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GMP

FDA has decided no GMP device since 2007.

Median 510(k) review, days · GMP

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

Recalls per year · GMP

No recall names GMP since 2007.

Adverse event reports per year · GMP

No MAUDE report names GMP since 2007.

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—00
20120—00
20130—00
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—

What is it indicated for?

Ampcor RPR control kit i3 designed as an unassayed control material to monitor the

precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three

Teaction levels.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Recent decisions in GMP

The GMP category page

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  • K885298Visuwell Reagin Test 960 Test KitAllelix Diagnostics, Inc. · 1989
  • K875180V-Trend RPRL Card TestTexas Immunology, Inc. · 1988
  • K851504VDRL Carbon Antigen Test S900500, S900250 & S90010Ncs Diagnostics, Inc. · 1985

https://510kreport.com/device/K980638 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980638: Adi Syphilis RPR Liquid Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980638

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026