Cleared Traditional

K884430 - SERUM HCG MICROASSAY

K884430 is the FDA 510(k) clearance for SERUM HCG MICROASSAY by Diamedix Corp.. It is a Class 2 Chemistry device (product code DHA) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K884430 · Diamedix Corp. · Chemistry device
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Dec 1988
Decision
49d
Days
Class 2
Risk

K884430 is an FDA 510(k) clearance for the SERUM HCG MICROASSAY. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 Diamedix Corp. devices

Submission Details

510(k) Number K884430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1988
Decision Date December 09, 1988
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHA System, Test, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - DHA System, Test, Human Chorionic Gonadotropin

All 38
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K884430.
STATUS HCG FLUOROMETRIC ENZYME
K893577 · Baxter Healthcare Corp · Aug 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · Leeco Diagnostics, Inc. · Jun 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · Leeco Diagnostics, Inc. · Jun 1989
IMMUKNOW-CHECK HCG ASSAY KIT, CAT. #900-40
K883148 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1988
RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO
K884207 · Abbott Laboratories · Dec 1988
MODIFIED VENTRESCREEN BETA HCG ENZYME IMMUNOASSAY
K880678 · Ventrex Laboratories, Inc. · Apr 1988