Cleared Traditional

K943029 - IRON QVET

K943029 is an FDA 510(k) clearance for IRON QVET, manufactured by Prisma Systems. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K943029 · Prisma Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
158d
Days
Class 1
Risk

K943029 is an FDA 510(k) clearance for the IRON QVET. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 158 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Prisma Systems devices

FDA 510(k) Submission Details - K943029

510(k) Number K943029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date December 02, 1994
Days to Decision 158 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 88d · This submission: 158d
Pathway characteristics
Predicate-based equivalence.

JIY Device Classification - Class 1, General Controls

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - JIY Photometric Method, Iron (non-heme)

All 52
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K943029.
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · Diagnostic Chemicals , Ltd. · Nov 1997
IL TEST IRON
K972363 · Instrumentation Laboratory CO · Aug 1997
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588 · Pointe Scientific, Inc., · Nov 1996
DMA IRON PROCEDURE
K944462 · Data Medical Associates, Inc. · Nov 1994
IRON TEST
K935176 · Em Diagnostic Systems, Inc. · Dec 1993
IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R
K930166 · Em Diagnostic Systems, Inc. · Apr 1993