Cleared Traditional

K831984 - POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE

K831984 is an FDA 510(k) clearance for POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE, manufactured by Diagnostic Reagent Tech.. The device is a Class 2 Microbiology device with product code DGO cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K831984 · Diagnostic Reagent Tech. · Microbiology device
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Nov 1983
Decision
154d
Days
Class 2
Risk

K831984 is an FDA 510(k) clearance for the POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by Diagnostic Reagent Tech. (Walker, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 154 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5510 - the FDA microbiology device 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Reagent Tech. devices

FDA 510(k) Submission Details - K831984

510(k) Number K831984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1983
Decision Date November 21, 1983
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGO Device Classification - Class 2, Special Controls

Product Code DGO Ige, Peroxidase, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Microbiology devices follow this clearance model.

Regulatory Peers - DGO Ige, Peroxidase, Antigen, Antiserum, Control

All 9
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K831984.
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · Beckman Instruments, Inc. · Jun 1989
ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5
K872801 · Diagnostic Products Corp. · Sep 1987
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM
K860851 · Nichols Institute Diagnostics · Mar 1986
EPSILON IGE TEST KIT
K831987 · Beckman Instruments, Inc. · Oct 1983
IMMUNOGLOBULIN E TEST KIT
K800995 · Calbiochem-Behring Corp. · May 1980