Cleared Traditional

K872897 - TSH SEROZYME IMMUNOENZYMETRIC KIT

K872897 is the FDA 510(k) clearance for TSH SEROZYME IMMUNOENZYMETRIC KIT by Serono Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JLW) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K872897 · Serono Diagnostics, Inc. · Chemistry device
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Jul 1987
Decision
8d
Days
Class 2
Risk

K872897 is an FDA 510(k) clearance for the TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA.. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 8 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K872897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1987
Decision Date July 31, 1987
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 88d · This submission: 8d
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 146
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K872897.
REAGENTS FOR TSH ASSAY
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ABBOTT IMX HTSH
K880086 · Abbott Laboratories · Apr 1988
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093
K874061 · Medix Biotech, Inc. · Nov 1987
IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
K872305 · Diagnostic Products Corp. · Jul 1987
MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT
K870904 · Micromedic Systems · May 1987
AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT
K871505 · Micromedic Systems · May 1987