Cleared Traditional

K841606 - BLOOD SPOT NEONATAL TSH RADIOIMMUNO

K841606 is an FDA 510(k) clearance for BLOOD SPOT NEONATAL TSH RADIOIMMUNO, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Chemistry device with product code JLW cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K841606 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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May 1984
Decision
33d
Days
Class 2
Risk

K841606 is an FDA 510(k) clearance for the BLOOD SPOT NEONATAL TSH RADIOIMMUNO. Classified as Radioimmunoassay, Thyroid-stimulating Hormone (product code JLW), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 33 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K841606

510(k) Number K841606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1984
Decision Date May 22, 1984
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
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 202
Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K841606.
ACCUSCREEN TSH
K843281 · Neometrics, Inc. · Sep 1984
SUCROSEP THYROID STIMULATING HORMONE
K842593 · Boots-Celltech Diagnostics, Inc. · Sep 1984
AMERLEX-M TSH RIA
K842948 · Amersham Corp. · Sep 1984
BIODEX ACT-O-KIT TSH-RIA-
K840088 · Biodan Medical Systems, Ltd. · May 1984
SERUM THYROTROPIN ASSAY KIT, TIPSEP-
K833713 · Nuclear Diagnostics, Inc. · Dec 1983
TANDEM-E THYROID STIMULATING HORMONE KIT
K832813 · Hybritech, Inc. · Oct 1983