Cleared Traditional

K023483 - KALAZAR DETECT

K023483 is an FDA 510(k) clearance for KALAZAR DETECT, manufactured by Inbios Intl., Inc.. The device is a Class 1 Microbiology device with product code LOO cleared through the Traditional 510(k) pathway after a 201-day FDA review.

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

FDA 510(k) Submission Details - K023483

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.

LOO Device Classification - Class 1, General Controls

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.