Cleared Traditional

K090846 - GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

K090846 is an FDA 510(k) clearance for GSP INSTRUMENT AND GSP NEONATAL HTSH KIT, manufactured by Perkinelmer, Inc.. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K090846 · Perkinelmer, Inc. · Chemistry device
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Sep 2009
Decision
157d
Days
Class 2
Risk

K090846 is an FDA 510(k) clearance for the GSP INSTRUMENT AND GSP NEONATAL HTSH KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 3, 2009 after a review of 157 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1690 - 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.

View all Perkinelmer, Inc. devices

FDA 510(k) Submission Details - K090846

510(k) Number K090846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2009
Decision Date September 03, 2009
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 88d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JLW Device Classification - Class 2, Special Controls

Product Code JLW Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1690
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.

Regulatory Peers - JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 165
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