510(k) Report

510(k) · Cleared

Cleared

Kalazar Detect

K023483510(k) TraditionalCleared May 6, 2003201-day reviewClass I21 CFR 866.3870

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

Inbios Intl., Inc. · LOO Reagent, Leishmanii Serological

Cleared on May 6, 2003 after a 201-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
May 6, 2003
Review
201 days
Class
Class I
Product code
LOO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K023483Source: 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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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 LOO devices

LOO Reagent, Leishmanii Serological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LOO

FDA has decided no LOO device since 2007.

Median 510(k) review, days · LOO

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

Recalls per year · LOO

No recall names LOO since 2007.

Adverse event reports per year · LOO

No MAUDE report names LOO 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?

The Kalazar DetectTMTest is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.

Indications for use as stated in the FDA 510(k) statement.

More from Inbios Intl., Inc.

6 FDA decisions under this applicant name. See the company

  • DEN100020Denv Detect Igm Capture ElisaInbios Intl., Inc. · 2011
  • K041817West Nile Detect Igm ElisaInbios Intl., Inc. · 2004
  • K001092Generic Blood Glucose Test StripInbios Intl., Inc. · 2000
  • K992695Insure Pro TestInbios Intl., Inc. · 1999
  • K991515Insure Pregnancy TestInbios Intl., Inc. · 1999

Recent decisions in LOO

The LOO category page

  • K842526Amizyme-Leishmania SPP. Test KitAmico Lab, Inc. · 1984

https://510kreport.com/device/K023483 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023483: Kalazar Detect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023483

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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