Cleared Traditional

K772328 - LAS-R HUMAN ANTITHROMBIN III TEST

K772328 is an FDA 510(k) clearance for LAS-R HUMAN ANTITHROMBIN III TEST, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 2 Immunology device with product code JBQ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K772328 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
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Feb 1978
Decision
44d
Days
Class 2
Risk

K772328 is an FDA 510(k) clearance for the LAS-R HUMAN ANTITHROMBIN III TEST. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special 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 864.7060 - 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 - K772328

510(k) Number K772328 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 105d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBQ Device Classification - Class 2, Special Controls

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 47
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K772328.
ASSAY, CHROMOGENIC ANTITHROMBIN III
K781860 · Ortho Diagnostics, Inc. · Dec 1978
ANTITHROMBIN III ASSAY
K781480 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1978
ANTITHROMBIN III SERUM, ANTI-HUMAN
K781026 · Icl Scientific · Aug 1978
ANTITHROMBIN III ASSAY
K780002 · Ortho Diagnostics, Inc. · Jan 1978
DIAG. KIT FOR TOTAL ANTITHROMBIN III
K771669 · Abbott Laboratories · Nov 1977
PHADECODE DIFFERENTIAL FACTOR XA1 ASSAY
K770942 · Pharmaseal Div., Baxter Healthcare Corp. · Jul 1977