Cleared Traditional

IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) (K883267) - FDA 510(k) Clearance

Class I Chemistry device.

K883267 · Diagnostic Products Corp. · Chemistry device
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Oct 1988
Decision
89d
Days
Class 1
Risk

K883267 is an FDA 510(k) clearance for the IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN). Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 89 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K883267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1988
Decision Date October 31, 1988
Days to Decision 89 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
1d slower than avg
Panel avg: 88d · This submission: 89d
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 88
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K883267.
IDS-iSYS Total Testosterone
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Access SHBG
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Access Testosterone
K223405 · Beckman Coulter, Inc. · Jan 2023
Elecsys Testosterone II
K211685 · Roche Diagnostics · May 2022
LIAISON Testosterone xt
K201908 · DiaSorin, Inc. · Oct 2020