Cleared Traditional

K770406 - TECHNICON SMA & AAII SYSTEMS

K770406 is an FDA 510(k) clearance for TECHNICON SMA & AAII SYSTEMS, manufactured by Boehringer Laboratories. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K770406 · Boehringer Laboratories · Chemistry device
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Jun 1977
Decision
91d
Days
Class 2
Risk

K770406 is an FDA 510(k) clearance for the TECHNICON SMA & AAII SYSTEMS. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Boehringer Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 2, 1977 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Laboratories devices

FDA 510(k) Submission Details - K770406

510(k) Number K770406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1977
Decision Date June 02, 1977
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 Chemistry devices follow this clearance model.

Regulatory Peers - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K770406.
MULTISTAT III ALKALINE PHOSPHATASE
K771470 · Instrumentation Laboratory CO · Sep 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085 · J.T. Baker Chemical Co. · Aug 1977
ULTRAZYME PLUS ALP
K770870 · Harleco · Jul 1977
ALKALINE PHOSPHATASE ENZYMATIC
K770316 · Icn Pharmaceuticals, Inc. · Mar 1977
SIGMA PROCED #SC165
K760685 · Sigma Chemical Co. · Nov 1976
REAGENT, AMP BUFFER DIAGNOSTIC
K760397 · J.T. Baker Chemical Co. · Nov 1976