Cleared Traditional

K821545 - TANDEM PROLACTIN KIT

K821545 is an FDA 510(k) clearance for TANDEM PROLACTIN KIT, manufactured by Hybritech, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K821545

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.

CFT Device Classification - Class 1, General Controls

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 65

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

RIANEN PROLACTIN 125I KIT

K831345 · New England Nuclear · Jun 1983

RADIOIMMUNOASSAY TEST SYSTEM PRL

K830412 · Monobind · Apr 1983

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

FDA 510(k) Resources - Chemistry

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

About This 510(k) Record

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 . FDA decision: June 11, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

Verify on FDA.gov

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