Cleared Traditional

K884809 - DELFIA SHBG KIT

K884809 is the FDA 510(k) clearance for DELFIA SHBG KIT by Pharmacia, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K884809 · Pharmacia, Inc. · Chemistry device
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Mar 1989
Decision
111d
Days
Class 1
Risk

K884809 is an FDA 510(k) clearance for the DELFIA SHBG KIT. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on March 8, 1989 after a review of 111 days - within the typical 510(k) review window.

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: 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K884809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1988
Decision Date March 08, 1989
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
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 53
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K884809.
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
IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN)
K883267 · Diagnostic Products Corp. · Oct 1988
LEECO TESTOSTERONE DIAGNOSTIC KIT
K860003 · Leeco Diagnostics, Inc. · Mar 1986
DSL ACTIVE TESTOSTERONE RIA (DSL #4000)
K854671 · Diagnostic Systems Laboratories, Inc. · Dec 1985