Cleared Traditional

Q-CHECK CULTI-LOOPS (K830133) - FDA 510(k) Clearance

Class I Immunology device.

K830133 · Lab Ability, Inc. · Immunology device
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Feb 1983
Decision
27d
Days
Class 1
Risk

K830133 is an FDA 510(k) clearance for the Q-CHECK CULTI-LOOPS. Classified as Kit, Quality Control For Culture Media (product code JTR), Class I - General Controls.

Submitted by Lab Ability, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2480 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lab Ability, Inc. devices

Submission Details

510(k) Number K830133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1983
Decision Date February 09, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 104d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTR Kit, Quality Control For Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2480
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.