Cleared Traditional

K023483 - KALAZAR DETECT (FDA 510(k) Clearance)

Class I Microbiology device.

K023483 · Inbios Intl., Inc. · Microbiology device
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May 2003
Decision
201d
Days
Class 1
Risk

K023483 is an FDA 510(k) clearance for the KALAZAR DETECT. Classified as Reagent, Leishmanii Serological (product code LOO), Class I - General Controls.

Submitted by Inbios Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on May 6, 2003 after a review of 201 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3870 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Inbios Intl., Inc. devices

Submission Details

510(k) Number K023483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2002
Decision Date May 06, 2003
Days to Decision 201 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 102d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOO Reagent, Leishmanii Serological
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3870
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.