Cleared Traditional

K883996 - X-ACT LDC/IND

K883996 is the FDA 510(k) clearance for X-ACT LDC/IND by Pro-Lab, Inc.. It is a Class 1 Microbiology device (product code JSE) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K883996 · Pro-Lab, Inc. · Microbiology device
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Oct 1988
Decision
22d
Days
Class 1
Risk

K883996 is an FDA 510(k) clearance for the X-ACT LDC/IND. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Pro-Lab, Inc. (Buffalo, US). The FDA issued a Cleared decision on October 12, 1988 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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: 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 Pro-Lab, Inc. devices

Submission Details

510(k) Number K883996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1988
Decision Date October 12, 1988
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSE Culture Media, Multiple Biochemical Test

All 39
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K883996.
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CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES
K871096 · bioMerieux, Inc. · Apr 1987
BIOTIS LITMUS MILK
K862393 · Otisville Biotech, Inc. · Jul 1986