Cleared Traditional

K770406 - TECHNICON SMA & AAII SYSTEMS

K770406 is the FDA 510(k) clearance for TECHNICON SMA & AAII SYSTEMS by Boehringer Laboratories. It is a Class 2 Chemistry device (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

Submission Details

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.

Device Classification

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 83
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
SIGMA PROCED #SC165
K760685 · Sigma Chemical Co. · Nov 1976
REAGENT, AMP BUFFER DIAGNOSTIC
K760397 · J.T. Baker Chemical Co. · Nov 1976
REAGENT, MAGNESIUM CHLORIDE
K760398 · J.T. Baker Chemical Co. · Oct 1976