Cleared Traditional

K991316 - TOUCH TEAR IGE MICROASSAY KIT

K991316 is an FDA 510(k) clearance for TOUCH TEAR IGE MICROASSAY KIT, manufactured by Touch Scientific, Inc.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K991316 · Touch Scientific, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
112d
Days
Class 2
Risk

K991316 is an FDA 510(k) clearance for the TOUCH TEAR IGE MICROASSAY KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Touch Scientific, Inc. (Raleigh, US). The FDA issued a Cleared decision on August 9, 1999 after a review of 112 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Touch Scientific, Inc. devices

FDA 510(k) Submission Details - K991316

510(k) Number K991316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date August 09, 1999
Days to Decision 112 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
7d slower than avg
Panel avg: 105d · This submission: 112d
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 K991316.
RANDOX IGE
K010855 · Randox Laboratories, Ltd. · May 2001
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · The Binding Site, Ltd. · Oct 2000
BIOCHECK IGE ELISA, MODEL BC-1035
K992528 · Biocheck, Inc. · Sep 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
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · Boehringer Mannheim Corp. · Nov 1998