Cleared Traditional

K110274 - AUTODELFIA NEONATAL IRT KIT

K110274 is an FDA 510(k) clearance for AUTODELFIA NEONATAL IRT KIT, manufactured by Wallac Oy, A Subsidiary of Perkinelmer, Inc.. The device is a Class 1 Chemistry device with product code JNO cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K110274 · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
130d
Days
Class 1
Risk

K110274 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL IRT KIT. Classified as N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin (product code JNO), Class I - General Controls.

Submitted by Wallac Oy, A Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on June 10, 2011 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1725 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K110274

510(k) Number K110274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date June 10, 2011
Days to Decision 130 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 89d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

JNO Device Classification - Class 1, General Controls

Product Code JNO N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1725
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JNO N-benzoyl-l-arginine Ethyl Ester (u.v.), Trypsin

Devices cleared under the same product code (JNO) and FDA review panel - the closest regulatory comparables to K110274.
GSP NEONATAL IRT KIT (3306-001U)
K102419 · Wallac Oy, Subsidiary of Perkinelmer · Dec 2010
NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
K932406 · Nuclear Diagnostics, Inc. · Dec 1993
MRI NEO-TRYP TRYPSIN RIA
K883011 · Microbiological Research Corp. · Apr 1989
TRYPSIN RIA KIT
K861097 · Microanalytic Research, Inc. · May 1986
TRYPIN (125I) RIA KIT
K811805 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1981
RIA KIT FOR TRYPSIN
K791202 · Cis Radiopharmaceuticals, Inc. · Nov 1979
K110274 · AUTODELFIA NEONATAL IRT KIT
Download PDF FDA Summary Wallac Oy, A Subsidia…