Cleared Abbreviated

K121864 - PERKINELMER 226 SAMPLE COLLECTION DEVICES (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K121864 · Perkinelmer, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
259d
Days
Class 2
Risk

K121864 is an FDA 510(k) clearance for the PERKINELMER 226 SAMPLE COLLECTION DEVICES. Classified as Newborn Screening Specimen Collection Paper (product code PJC), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Greenville, US). The FDA issued a Cleared decision on March 12, 2013 after a review of 259 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Perkinelmer, Inc. devices

Submission Details

510(k) Number K121864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2012
Decision Date March 12, 2013
Days to Decision 259 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 88d · This submission: 259d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PJC Newborn Screening Specimen Collection Paper
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition Newborn Screening Specimen Collection Paper Is A Blood Collection Device Intended To Be Used As Medium To Collect And Transport Whole Blood Specimens From Newborns To The Laboratory For In Vitro Diagnostic Analysis.
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 Chemistry devices follow this clearance model.