Cleared Traditional

N-A-G TEST KIT (K893582) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893582 · Ppr Diagnostics , Ltd. · Chemistry device
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Oct 1990
Decision
510d
Days
Class 2
Risk

K893582 is an FDA 510(k) clearance for the N-A-G TEST KIT. Classified as Alkaline Picrate, Colorimetry, Creatinine (product code CGX), Class II - Special Controls.

Submitted by Ppr Diagnostics , Ltd. (Fort Worth, US). The FDA issued a Cleared decision on October 1, 1990 after a review of 510 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Ppr Diagnostics , Ltd. devices

Submission Details

510(k) Number K893582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date October 01, 1990
Days to Decision 510 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
422d slower than avg
Panel avg: 88d · This submission: 510d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGX Alkaline Picrate, Colorimetry, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - CGX Alkaline Picrate, Colorimetry, Creatinine

All 39
Devices cleared under the same product code (CGX) and FDA review panel - the closest regulatory comparables to K893582.
SYNCHRON CREATININE TRIGGERED TEST CX4,5,7,
K915077 · Beckman Instruments, Inc. · Dec 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
K913707 · Em Diagnostic Systems, Inc. · Sep 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
K905658 · Em Diagnostic Systems, Inc. · May 1991
ROCHE COBAS READY CREATININE REAGENT
K902561 · Roche Diagnostic Systems, Inc. · Sep 1990
SYSTEMATE CREATININE TEST (CREA) #65413
K895022 · Em Diagnostic Systems, Inc. · Oct 1989
CREATININE TEST (CREA) ITEM #65663
K884734 · Em Diagnostic Systems, Inc. · Dec 1988