Cleared Traditional

K801849 - LACTI-QUANT

K801849 is an FDA 510(k) clearance for LACTI-QUANT, manufactured by Nuclear Medical Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CFT cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K801849 · Nuclear Medical Laboratories, Inc. · Chemistry device
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Sep 1980
Decision
43d
Days
Class 1
Risk

K801849 is an FDA 510(k) clearance for the LACTI-QUANT. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Nuclear Medical Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 43 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 Nuclear Medical Laboratories, Inc. devices

FDA 510(k) Submission Details - K801849

510(k) Number K801849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1980
Decision Date September 16, 1980
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K801849.
LEECO PRL-QUANT DIAGNOSTIC TEST KIT
K820039 · Leeco Diagnostics, Inc. · Jan 1982
MARRIA-HPRL RIA KIT
K812112 · Intl. Immunoassay Laboratories, Inc. · Aug 1981
PROLACTIN (125) RADIOIMMUNAOASSAY
K803273 · Corning Medical & Scientific · Jan 1981
GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-
K801020 · Travenol Laboratories, S.A. · Jul 1980
PROLACTIN RIA KIT
K800740 · Amersham Corp. · Apr 1980
125 I PROLACTIN HORMONE RIA KIT
K792166 · Diagnostic Products Corp. · Nov 1979