Cleared Traditional

K900775 - NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM

K900775 is an FDA 510(k) clearance for NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM, manufactured by Bio-Rad. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K900775 · Bio-Rad · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
17d
Days
Class 1
Risk

K900775 is an FDA 510(k) clearance for the NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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.

FDA 510(k) Submission Details - K900775

510(k) Number K900775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date March 09, 1990
Days to Decision 17 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
72d faster than avg
Panel avg: 89d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K900775.
MICROPLATE REAGENT DISPENSER
K900599 · Denley Instruments, Inc. · May 1990
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
K896684 · Schiff & Co. · Apr 1990
EXEC-WASH SOLID PHASE WASHING SYSTEM
K896631 · Source Scientific Systems, Inc. · Apr 1990
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K897158 · Abbott Laboratories · Mar 1990
SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM
K893811 · Sakura Finetek U.S.A., Inc. · Sep 1989
DPC-ROBOSTAT(TM)
K894710 · Diagnostic Products Corp. · Aug 1989
K900775 · NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
Download PDF Bio-Rad