Cleared Traditional

K912850 - SHBG

K912850 is the FDA 510(k) clearance for SHBG by Wien Laboratories, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K912850 · Wien Laboratories, Inc. · Chemistry device
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Aug 1991
Decision
45d
Days
Class 1
Risk

K912850 is an FDA 510(k) clearance for the SHBG. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Wien Laboratories, Inc. (Succasunna, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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 Wien Laboratories, Inc. devices

Submission Details

510(k) Number K912850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date August 12, 1991
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 54
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K912850.
CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY
K934562 · Ciba Corning Diagnostics Corp. · Dec 1993
DSL ACTIVE SHBG (DSL 7400)
K915823 · Diagnostic Systems Laboratories, Inc. · Mar 1992
GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT
K915570 · Incstar Corp. · Jan 1992
SHBG IRMA KIT
K905247 · Ventrex Laboratories, Inc. · Jan 1991
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)
K904100 · Diagnostic Systems Laboratories, Inc. · Oct 1990
DELFIA SHBG KIT
K884809 · Pharmacia, Inc. · Mar 1989