Cleared Traditional

K852573 - TECHNICON RA-1000 SYSTEM ANALYTE THEOPH...

K852573 is the FDA 510(k) clearance for TECHNICON RA-1000 SYSTEM ANALYTE THEOPH... by Technicon Instruments Corp.. It is a Class 2 Toxicology device (product code KLS) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K852573 · Technicon Instruments Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
24d
Days
Class 2
Risk

K852573 is an FDA 510(k) clearance for the TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3880 - the FDA toxicology 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K852573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date July 12, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 Toxicology devices follow this clearance model.

Regulatory Peers - KLS Enzyme Immunoassay, Theophylline

All 55
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K852573.
IN VITRO TEST DETERMINATION OF THEOPHYLLINE
K854183 · Clinical Data, Inc. · Dec 1985
VISION THEOPHYLLINE
K853834 · Abbott Laboratories · Oct 1985
GEMSTAR IPA THEOPHYLLINE TEST KIT
K853372 · Electro-Nucleonics Laboratories, Inc. · Sep 1985
ACCULEVEL THEOPHYLLINE TEST(MODIFICATION)
K851741 · Syva Co. · Jun 1985
ICS THEOPHYLLINE REAGENTS
K850856 · Beckman Instruments, Inc. · Mar 1985
ACCULEVEL THEOPHYLLINE TEST
K844642 · Syva Co. · Mar 1985