Cleared Traditional

NOVASPEC VISIBLE SPECTROPHOTOMETER (K851572) - FDA 510(k) Clearance

Class I Toxicology device.

K851572 · Lkb Instruments, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
33d
Days
Class 1
Risk

K851572 is an FDA 510(k) clearance for the NOVASPEC VISIBLE SPECTROPHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 20, 1985 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2300 - 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 Lkb Instruments, Inc. devices

Submission Details

510(k) Number K851572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1985
Decision Date May 20, 1985
Days to Decision 33 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 87d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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.

Regulatory Peers - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 257
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K851572.
SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM
K943595 · Instrumentation Laboratory CO · Nov 1994
BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
K932778 · Boehringer Mannheim Corp. · Nov 1993
ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM
K932467 · Instrumentation Laboratory CO · Nov 1993
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K921180 · Roche Diagnostic Systems, Inc. · Jul 1992
AMERLITE PROCESSING CENTER
K915680 · Eastman Kodak Company · Mar 1992
MICROTAK PLUS
K913840 · Syva Co. · Sep 1991