Cleared Traditional

K991387 - ELAN ALKALINE PHOSPHATE REAGENT KIT

K991387 is an FDA 510(k) clearance for ELAN ALKALINE PHOSPHATE REAGENT KIT, manufactured by Elan Holdings, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K991387 · Elan Holdings, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
28d
Days
Class 2
Risk

K991387 is an FDA 510(k) clearance for the ELAN ALKALINE PHOSPHATE REAGENT KIT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on May 19, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Elan Holdings, Inc. devices

FDA 510(k) Submission Details - K991387

510(k) Number K991387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date May 19, 1999
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 114
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K991387.
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · Diagnostic Chemicals , Ltd. · Nov 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · Teco Diagnostics · Jan 2000
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762 · A.P. Total Care, Inc. · Sep 1999
CARESIDE ALKALINE PHOSPHATASE
K990024 · Careside, Inc. · Jan 1999
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
K981897 · Roche Diagnostic Systems, Inc. · Aug 1998
ALKP
K981806 · Abbott Laboratories · Jun 1998