Cleared Traditional

K992528 - BIOCHECK IGE ELISA, MODEL BC-1035

K992528 is an FDA 510(k) clearance for BIOCHECK IGE ELISA, manufactured by Biocheck, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K992528 · Biocheck, Inc. · Immunology device
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Sep 1999
Decision
55d
Days
Class 2
Risk

K992528 is an FDA 510(k) clearance for the BIOCHECK IGE ELISA, MODEL BC-1035. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on September 21, 1999 after a review of 55 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.

View all Biocheck, Inc. devices

FDA 510(k) Submission Details - K992528

510(k) Number K992528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1999
Decision Date September 21, 1999
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 105d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

Product Code DGC Ige, 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 - DGC Ige, Antigen, Antiserum, Control

All 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K992528.
IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR
K024210 · Beckman Coulter, Inc. · Feb 2003
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000
TOUCH TEAR IGE MICROASSAY KIT
K991316 · Touch Scientific, Inc. · Aug 1999
PHARMACIA CAP SYSTEM IGE FEIA, MODEL 10-9395-01
K991945 · Pharmacia & Upjohn Co. · Jul 1999
N LATEX IGE MONO REAGENT
K991787 · Dade Behring, Inc. · Jul 1999