Cleared Traditional

K881627 - DELFIA(TM) NEONATAL HTSH KIT

K881627 is an FDA 510(k) clearance for DELFIA(TM) NEONATAL HTSH KIT, manufactured by Pharmacia, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K881627

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.

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 200
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K881627.
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · Ventrex Laboratories, Inc. · Feb 1989
MODIFIED TSH IRMA KIT
K883742 · Pacific Biotech, Inc. · Jan 1989
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL
K883726 · Immuchem Corp. · Dec 1988
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