Cleared Traditional

K830133 - Q-CHECK CULTI-LOOPS

K830133 is an FDA 510(k) clearance for Q-CHECK CULTI-LOOPS, manufactured by Lab Ability, Inc.. The device is a Class 1 Immunology device with product code JTR cleared through the Traditional 510(k) pathway after a 27-day FDA review.

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

FDA 510(k) Submission Details - K830133

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
78d faster than avg
Panel avg: 105d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JTR Device Classification - Class 1, General Controls

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.

Regulatory Peers - JTR Kit, Quality Control For Culture Media

Devices cleared under the same product code (JTR) and FDA review panel - the closest regulatory comparables to K830133.
PROTECT T.M.
K871121 · Pro-Lab, Inc. · Apr 1987
B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS
K842579 · Biological & Environmental Control Laboratories · Jul 1984
LYOPHILIZED MICROORGANISMS
K831653 · Austin Biological Laboratories · Jul 1983
BIO-CHECK GRAM STAIN CONTROL
K821660 · American Scientific Products · Jun 1982
GC DISK
K812698 · Remel Co. · Oct 1981