Cleared Traditional

K821545 - TANDEM PROLACTIN KIT

K821545 is the FDA 510(k) clearance for TANDEM PROLACTIN KIT by Hybritech, Inc.. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K821545 · Hybritech, Inc. · Chemistry device

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Jun 1982

Decision

17d

Days

Class 1

Risk

K821545 is an FDA 510(k) clearance for the TANDEM PROLACTIN KIT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Hybritech, Inc. devices

Submission Details

510(k) Number	K821545 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 25, 1982
Decision Date	June 11, 1982
Days to Decision	17 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

71d faster than avg

Panel avg: 88d · This submission: 17d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	CFT Radioimmunoassay, Prolactin (lactogen)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1625

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CFT Radioimmunoassay, Prolactin (lactogen)

All 49

Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K821545.

PROLACTIN RIABEAD PROLACTIN RADIOIMM

K841118 · Abbott Laboratories · May 1984

COAT-A-COUNT NHS-PROLACTIN KIT AND

K833925 · Diagnostic Products Corp. · Jan 1984

ABBOTT LABORATORIES PROLACTIN EIA

K822759 · Abbott Laboratories · Oct 1982

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT

K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982

CENTRIA PROLACTIN TEST SET

K813572 · Ventrex Laboratories, Inc. · Mar 1982

LEECO PRL-QUANT DIAGNOSTIC TEST KIT

K820039 · Leeco Diagnostics, Inc. · Jan 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 K821545

Hybritech, Inc.

Mchenry, IL · US

Regulatory profile

63 submissions 63 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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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.

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