Cleared Traditional

K953939 - QUINTEST

K953939 is an FDA 510(k) clearance for QUINTEST, manufactured by Bayer Corp.. The device is a Class 2 General Hospital device with product code SCL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K953939 · Bayer Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
90d
Days
Class 2
Risk

K953939 is an FDA 510(k) clearance for the QUINTEST. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Bayer Corp. (Spokane, US). The FDA issued a Cleared decision on November 13, 1995 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K953939

510(k) Number K953939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1995
Decision Date November 13, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
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: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SCL Device Classification - Class 2, Special Controls

Product Code SCL Allergen And Vaccine Delivery Needles
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
Definition An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.
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 General Hospital devices follow this clearance model.

Regulatory Peers - SCL Allergen And Vaccine Delivery Needles

All 24
Devices cleared under the same product code (SCL) and FDA review panel - the closest regulatory comparables to K953939.
DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
K000299 · Biomedex, Inc. · Apr 2000
QUANTI-TEST SYSTEM
K982578 · Panatrex, Inc. · Sep 1998
MULTI-TEST II
K961918 · Lincoln Diagnostics, Inc. · Aug 1996
DUOTIP-TEST
K941820 · Lincoln Diagnostics, Inc. · Sep 1994
DISPOSABLE MULTI-PUNCTURE APPLICATOR
K922177 · Allergy Extract Co. · Jun 1993
GREER DERMAPIK SYSTEM
K890360 · Greer Laboratories, Inc. · Jun 1989
K953939 · QUINTEST
Download PDF FDA Summary Bayer Corp.