Cleared Traditional

K930501 - DU PONT ACA NEV/EEV VERIFIER

K930501 is an FDA 510(k) clearance for DU PONT ACA NEV/EEV VERIFIER, manufactured by Dupont Medical Products. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K930501 · Dupont Medical Products · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
189d
Days
Class 2
Risk

K930501 is an FDA 510(k) clearance for the DU PONT ACA NEV/EEV VERIFIER. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on August 9, 1993 after a review of 189 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K930501

510(k) Number K930501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date August 09, 1993
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 96
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K930501.
URINARY ALBUMIN CALIBRATOR
K936201 · Dupont Medical Products · Mar 1994
KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · King Diagnostics, Inc. · Aug 1993
DC-LINEATE CAT. NO. SE-091
K932555 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1993
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
K922646 · Behring Diagnostics, Inc. · Jun 1993
ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR
K930477 · Analytical Control Systems, Inc. · Jun 1993
DC-UIBC-CAL
K925877 · Diagnostic Chemicals, Ltd. (Usa) · Mar 1993