Cleared Traditional

K881627 - DELFIA(TM) NEONATAL HTSH KIT

K881627 is the FDA 510(k) clearance for DELFIA(TM) NEONATAL HTSH KIT by Pharmacia, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K881627 · Pharmacia, Inc. · Chemistry device
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Oct 1988
Decision
174d
Days
Class 2
Risk

K881627 is an FDA 510(k) clearance for the DELFIA(TM) NEONATAL HTSH KIT. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on October 3, 1988 after a review of 174 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K881627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1988
Decision Date October 03, 1988
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 143
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K881627.
COTUBE(TM) TSH IRMA
K890802 · Bio-Rad · Mar 1989
TSH MICROASSAY
K890579 · Diamedix Corp. · Mar 1989
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · Ventrex Laboratories, Inc. · Feb 1989
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · Amersham Corp. · Sep 1988
VENTREX COATED TUBE TSH
K883342 · Ventrex Laboratories, Inc. · Sep 1988
REAGENTS FOR TSH ASSAY
K881381 · Sclavo, Inc. · Jul 1988