Cleared Traditional

ABBOTT LABORATORIES PROLACTIN EIA (K822759) - FDA 510(k) Clearance

Class I Chemistry device.

K822759 · Abbott Laboratories · Chemistry device

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Oct 1982

Decision

37d

Days

Class 1

Risk

K822759 is an FDA 510(k) clearance for the ABBOTT LABORATORIES PROLACTIN EIA. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 21, 1982 after a review of 37 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 Abbott Laboratories devices

Submission Details

510(k) Number	K822759 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 1982
Decision Date	October 21, 1982
Days to Decision	37 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

51d faster than avg

Panel avg: 88d · This submission: 37d

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 25

Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K822759.

TERUMO SENSIBEAD EIA HPRL KIT

K854768 · Terumo Medical Corp. · Jan 1986

PROLACTIN RIABEAD PROLACTIN RADIOIMM

K841118 · Abbott Laboratories · May 1984

COAT-A-COUNT NHS-PROLACTIN KIT AND

K833925 · Diagnostic Products Corp. · Jan 1984

PROLACTIN (125-I) RADIOIMMUNOASSAY KIT

K821305 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1982

GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-

K801020 · Travenol Laboratories, S.A. · Jul 1980

125 I PROLACTIN HORMONE RIA KIT

K792166 · Diagnostic Products Corp. · Nov 1979

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 K822759

Abbott Laboratories

Abbott Park, IL · US

Regulatory profile

883 submissions 868 cleared

98% 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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