Cleared Traditional

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS (K955448) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955448 · Behring Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
86d
Days
Class 2
Risk

K955448 is an FDA 510(k) clearance for the EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS. Classified as Radioimmunoassay, Lsd (125-i) (product code DLB), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on February 23, 1996 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3580 - the FDA toxicology 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K955448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1995
Decision Date February 23, 1996
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 87d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLB Radioimmunoassay, Lsd (125-i)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DLB Radioimmunoassay, Lsd (125-i)

Devices cleared under the same product code (DLB) and FDA review panel - the closest regulatory comparables to K955448.
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
K961436 · Roche Diagnostic Systems, Inc. · Jun 1996
COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT
K891167 · Diagnostic Products Corp. · May 1989
REVISED LABELING FOR LSD TEST KIT
K874270 · Roche Diagnostic Systems, Inc. · Nov 1987
ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD
K860525 · Roche Diagnostic Systems, Inc. · Apr 1986