Cleared Traditional

K772329 - LAS-R HUMAN PREALBUMIN TEST

K772329 is an FDA 510(k) clearance for LAS-R HUMAN PREALBUMIN TEST, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 1 Immunology device with product code JZJ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K772329 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
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Feb 1978
Decision
44d
Days
Class 1
Risk

K772329 is an FDA 510(k) clearance for the LAS-R HUMAN PREALBUMIN TEST. Classified as Prealbumin, Antigen, Antiserum, Control (product code JZJ), Class I - General Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5060 - the FDA immunology device 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 Hyland Therapeutic Div., Travenol Laboratories devices

FDA 510(k) Submission Details - K772329

510(k) Number K772329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1977
Decision Date February 03, 1978
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 105d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

JZJ Device Classification - Class 1, General Controls

Product Code JZJ Prealbumin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5060
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.