Cleared Traditional

K771912 - LAS-R BETA LIPOPROTEIN TEST

K771912 is an FDA 510(k) clearance for LAS-R BETA LIPOPROTEIN TEST, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 2 Immunology device with product code DFC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K771912 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
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Oct 1977
Decision
8d
Days
Class 2
Risk

K771912 is an FDA 510(k) clearance for the LAS-R BETA LIPOPROTEIN TEST. Classified as Lipoprotein, Low-density, Antigen, Antiserum, Control (product code DFC), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 19, 1977 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5600 - 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 - K771912

510(k) Number K771912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1977
Decision Date October 19, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 105d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DFC Device Classification - Class 2, Special Controls

Product Code DFC Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.