Cleared Traditional

BLOOD SPOT NEONATAL TSH RADIOIMMUNO (K841606) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841606 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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

Submission Details

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.

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 69

Devices cleared under the same product code (JLW) and FDA review panel - the closest regulatory comparables to K841606.

TSH-IRMA COAT-A-COUNT KIT

K860054 · Diagnostic Products Corp. · Mar 1986

TERUMO SENSIBEAD EIA TSH KIT

K850376 · Terumo Medical Corp. · Mar 1985

ABBOTT HTSH EIA DIAGNOSTIC KIT

K843540 · Abbott Laboratories · Nov 1984

EPSILON TSH TEST KIT

K831972 · Beckman Instruments, Inc. · Sep 1983

HISH EIA DIAGNOSTIC KIT

K822827 · Abbott Laboratories · Oct 1982

QUANTIMUNE HTSH IRMA

K822291 · Bio-Rad · Aug 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K841606

Bd Becton Dickinson Vacutainer Systems Preanalytic

Washington, DC · US

Regulatory profile

632 submissions 625 cleared

99% clearance rate · Active in Chemistry

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,218

Regulatory data since 1976

FDA monthly sync Active