Cleared Traditional

K830653 - POLYSTYRENE MICROTITER PLATE IMMUNOSORB

K830653 is an FDA 510(k) clearance for POLYSTYRENE MICROTITER PLATE IMMUNOSORB, manufactured by Diagnostic Reagent Tech.. The device is a Class 2 Immunology device with product code DGO cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K830653 · Diagnostic Reagent Tech. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
38d
Days
Class 2
Risk

K830653 is an FDA 510(k) clearance for the POLYSTYRENE MICROTITER PLATE IMMUNOSORB. Classified as Ige, Peroxidase, Antigen, Antiserum, Control (product code DGO), Class II - Special Controls.

Submitted by Diagnostic Reagent Tech. (Mchenry, US). The FDA issued a Cleared decision on April 8, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K830653

510(k) Number K830653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1983
Decision Date April 08, 1983
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 105d · This submission: 38d
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 Immunology devices follow this clearance model.

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

All 14
Devices cleared under the same product code (DGO) and FDA review panel - the closest regulatory comparables to K830653.
POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE
K831984 · Diagnostic Reagent Tech. · Nov 1983
EPSILON IGE TEST KIT
K831987 · Beckman Instruments, Inc. · Oct 1983
LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
K831774 · Diagnostic Reagent Tech. · Jul 1983
POLYSTYRENE MICROTITER PLATE IMMUNOSOR
K830495 · Diagnostic Reagent Tech. · Apr 1983
IP SPECIFIC E
K821094 · Diagnostic Reagent Tech. · May 1982
IMMUNOGLOBULIN E TEST KIT
K800995 · Calbiochem-Behring Corp. · May 1980
K830653 · POLYSTYRENE MICROTITER PLATE IMMUNOSORB
Download PDF Diagnostic Reagent Te…