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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 24
Devices cleared under the same product code (SCL) and FDA review panel - the closest regulatory comparables to K003195.
UNIVEC BIFURCATED SLIDING SHEATH SYRINGE
K020500 · Univec, Inc. · Mar 2002
BIFURCATED VACCINATING NEEDLE
K012515 · Precision Medical Products, Inc. · Sep 2001
ALLERSHARP ALLERGY SKIN TESTER
K011979 · Hmb Medical Concepts, Ltd. · Sep 2001
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
K003195 · GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
Download PDF FDA Summary Greer Laboratories, I…