Cleared Traditional

K935362 - P-AMYLASE CONTROL

K935362 is an FDA 510(k) clearance for P-AMYLASE CONTROL, manufactured by Beckman. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K935362 · Beckman · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
84d
Days
Class 1
Risk

K935362 is an FDA 510(k) clearance for the P-AMYLASE CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Beckman (Brea, US). The FDA issued a Cleared decision on January 27, 1994 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: 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 Beckman devices

FDA 510(k) Submission Details - K935362

510(k) Number K935362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1993
Decision Date January 27, 1994
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 445
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K935362.
ASSURE URINE HCG CONTROL
K941130 · Quantimetrix Corp. · Jun 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · Analytical Control Systems, Inc. · Apr 1994
DOCUMENT(R) ZERO
K940568 · Casco Standards · Apr 1994
CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET
K934922 · Unipath , Ltd. · Dec 1993
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923 · Unipath , Ltd. · Dec 1993
SPQ MALB CONTROL LEVEL II
K934521 · Incstar Corp. · Nov 1993