Cleared Traditional

K955155 - DOCUMENT TDM ULTRA UNASSAYED CONTROL

K955155 is the FDA 510(k) clearance for DOCUMENT TDM ULTRA UNASSAYED CONTROL by Casco Standards. It is a Class 1 Chemistry device (product code DIF) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K955155 · Casco Standards · Chemistry device
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Dec 1995
Decision
37d
Days
Class 1
Risk

K955155 is an FDA 510(k) clearance for the DOCUMENT TDM ULTRA UNASSAYED CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Casco Standards (Yarmouth, US). The FDA issued a Cleared decision on December 20, 1995 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3280 - the FDA in vitro diagnostics and chemistry 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 Casco Standards devices

Submission Details

510(k) Number K955155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date December 20, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 - DIF Drug Mixture Control Materials

All 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K955155.
U-DOA CONTROLS
K961724 · Medical Diagnostic Technologies, Inc. · Jun 1996
DOCUMENT TDM ULTRA ASSAYED CONTROL
K960244 · Casco Standards · Mar 1996
LYPHOCHEK BENZO/TCA CONTROL-SET B
K955153 · Bio-Rad · Feb 1996
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799 · Roche Diagnostic Systems, Inc. · Dec 1995
OPUS TDM CONTROLS
K954291 · Behring Diagnostics, Inc. · Nov 1995
TRI-POINT LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL
K954322 · Medical Analysis Systems, Inc. · Oct 1995