Cleared Traditional

K944059 - PROCHEQ 1 & 2

K944059 is an FDA 510(k) clearance for PROCHEQ 1 & 2, manufactured by Prisma Systems. The device is a Class 1 Toxicology device with product code JJY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K944059 · Prisma Systems · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
88d
Days
Class 1
Risk

K944059 is an FDA 510(k) clearance for the PROCHEQ 1 & 2. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on November 15, 1994 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1660 - 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 Prisma Systems devices

FDA 510(k) Submission Details - K944059

510(k) Number K944059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1994
Decision Date November 15, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 87d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 485
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K944059.
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)
K944455 · Beckman Instruments, Inc. · Jan 1995
DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL
K945315 · Casco Standards · Dec 1994
QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE)
K944452 · Beckman Instruments, Inc. · Dec 1994
MULTI ANALYTE LINEARITY SET
K936245 · Teco Diagnostics · Oct 1994
BILIRUBIN PLUS/PEDIATRIC CONTROLS
K943290 · Medi-Tech, Inc. · Sep 1994
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
K943754 · Bionostics, Inc. · Sep 1994