Cleared Traditional

K141341 - CL DETECT RAPID TEST

K141341 is an FDA 510(k) clearance for CL DETECT RAPID TEST, manufactured by InBios International, Inc.. The device is a Class 1 Microbiology device with product code PIT cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K141341 · InBios International, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2014
Decision
177d
Days
Class 1
Risk

K141341 is an FDA 510(k) clearance for the CL DETECT RAPID TEST. Classified as Leishmania Spp. Antigen Detection Assay (product code PIT), Class I - General Controls.

Submitted by InBios International, Inc. (Seattle, US). The FDA issued a Cleared decision on November 14, 2014 after a review of 177 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 International, Inc. devices

FDA 510(k) Submission Details - K141341

510(k) Number K141341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date November 14, 2014
Days to Decision 177 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

PIT Device Classification - Class 1, General Controls

Product Code PIT Leishmania Spp. Antigen Detection Assay
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3870
Definition An In Vitro Diagnostic Test For The Detection Of Leishmania Spp. Antigens To Aid In The Diagnosis Of Leishmania Spp. Infection.
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.

Clinical Evidence

ClinicalTrials.gov
NCT01769612 Completed Observational

Evaluation of a Rapid Diagnostic Device, CL Detect, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

Evaluation of a Diagnostic Device, CL Detect Rapid Test, for the Diagnosis of Cutaneous Leishmaniasis in Tunisia

168
Patients (actual)
2
Sites
Condition studied Skin Diseases, Parasitic
Eligibility All sexes · 18 Years+
Principal investigator Afif Ben Salah, MD PhD
Sponsor U.S. Army Medical Research and Development Command
Started 2013-01-01 → Primary completion 2013-08-01 → Completed 2014-04-01
Primary outcome
Positive Result Comparison: CL Detect Rapid Test With Microscopy and Culture Results
View full study on ClinicalTrials.gov