Cleared Traditional

K760572 - SERALUTE

K760572 is the FDA 510(k) clearance for SERALUTE by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code CDX) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K760572 · Miles Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1976
Decision
82d
Days
Class 2
Risk

K760572 is an FDA 510(k) clearance for the SERALUTE. Classified as Radioimmunoassay, Total Thyroxine (product code CDX), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 23, 1976 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1700 - 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K760572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1976
Decision Date November 23, 1976
Days to Decision 82 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
6d faster than avg
Panel avg: 88d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDX Radioimmunoassay, Total Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1700
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 Chemistry devices follow this clearance model.

Regulatory Peers - CDX Radioimmunoassay, Total Thyroxine

All 68
Devices cleared under the same product code (CDX) and FDA review panel - the closest regulatory comparables to K760572.
NEONATAL T4 RIA KIT
K770241 · Diagnostic Products Corp. · Feb 1977
SPAC TM T4 RIA KIT
K770156 · Mallinckrodt Critical Care · Feb 1977
DATA-TOPE T4 RIA PROCEDURE
K761282 · Dade, Baxter Travenol Diagnostics, Inc. · Dec 1976
RADIOIMMUNOASSAY
K760227 · Kallestad Laboratories, Inc. · Jul 1976
TEST, RA, QUANTA-COUNT T-4
K760135 · Bio-Rad · Jul 1976