Cleared Traditional

K003195 - GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

K003195 is an FDA 510(k) clearance for GREERTRACK SKIN TESTING SYSTEM, manufactured by Greer Laboratories, Inc.. The device is a Class 2 General Hospital device with product code SCL cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K003195 · Greer Laboratories, Inc. · General Hospital
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Dec 2000
Decision
62d
Days
Class 2
Risk

K003195 is an FDA 510(k) clearance for the GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC. Classified as Allergen And Vaccine Delivery Needles (product code SCL), Class II - Special Controls.

Submitted by Greer Laboratories, Inc. (Lenoir, US). The FDA issued a Cleared decision on December 13, 2000 after a review of 62 days - a notably fast clearance cycle.

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: 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 Greer Laboratories, Inc. devices

FDA 510(k) Submission Details - K003195

510(k) Number K003195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2000
Decision Date December 13, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 9
Devices cleared under the same product code (SCL) and FDA review panel - the closest regulatory comparables to K003195.
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
K172062 · Medscience Science Research Group, Inc. · Mar 2018
Allerhope Allergy Skin Tester
K162917 · Procare Industrial Co., Limited · Aug 2017
BD ECLIPSE BIFURCATED NEEDLE
K032528 · Becton, Dickinson & CO · Sep 2003
QUANTI-TEST SYSTEM
K982578 · Panatrex, Inc. · Sep 1998
MULTI-TEST II
K961918 · Lincoln Diagnostics, Inc. · Aug 1996
QUINTEST
K953939 · Bayer Corp. · Nov 1995