Cleared Traditional

K940004 - AI-PHOTODIAGNOSTIC

K940004 is an FDA 510(k) clearance for AI-PHOTODIAGNOSTIC, manufactured by Pharmarceutical Discovery Corp.. The device is a Class 2 Chemistry device with product code CIB cleared through the Traditional 510(k) pathway after a 578-day FDA review.

K940004 · Pharmarceutical Discovery Corp. · Chemistry device
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Aug 1995
Decision
578d
Days
Class 2
Risk

K940004 is an FDA 510(k) clearance for the AI-PHOTODIAGNOSTIC. Classified as Radioimmunoassay, Angiotensin I And Renin (product code CIB), Class II - Special Controls.

Submitted by Pharmarceutical Discovery Corp. (Elmsford, US). The FDA issued a Cleared decision on August 4, 1995 after a review of 578 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1085 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Pharmarceutical Discovery Corp. devices

FDA 510(k) Submission Details - K940004

510(k) Number K940004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1994
Decision Date August 04, 1995
Days to Decision 578 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
490d slower than avg
Panel avg: 88d · This submission: 578d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIB Device Classification - Class 2, Special Controls

Product Code CIB Radioimmunoassay, Angiotensin I And Renin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1085
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 - CIB Radioimmunoassay, Angiotensin I And Renin

All 12
Devices cleared under the same product code (CIB) and FDA review panel - the closest regulatory comparables to K940004.
ACTIVE RENIN IRMA
K061758 · Diagnostic Systems Laboratories, Inc. · Jul 2006
NICHOLS ADVANTAGE DIRECT RENIN (CALIBRATORS, CALIBRATION VERIFIERS, CONTROLS, AND SAMPLE DILUENT)
K011128 · Nichols Institute Diagnostics · Sep 2001
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · Diagnostic Systems Laboratories, Inc. · May 1998
ACTIVE RENIN IMMUNORADIOMETRIC ASSAY
K925998 · Nichols Institute Diagnostics · Jan 1993
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1985
RENIN RADIOIMMUNOASSAY TEST KIT
K842966 · Serono Diagnostics, Inc. · Oct 1984