Cleared Traditional

K841918 - SIGMA PROCED. 245 ALKALINE PHOSPHATASE

K841918 is the FDA 510(k) clearance for SIGMA PROCED. 245 ALKALINE PHOSPHATASE by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K841918 · Sigma Diagnostics, Inc. · Chemistry device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Jun 1984

Decision

36d

Days

Class 2

Risk

K841918 is an FDA 510(k) clearance for the SIGMA PROCED. 245 ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 36 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number	K841918 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 09, 1984
Decision Date	June 14, 1984
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

52d faster than avg

Panel avg: 88d · This submission: 36d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 83

Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K841918.

VISION -FORMERLY PDA- ALKALINE PHOSPHATASE

K850110 · Abbott Laboratories · Jan 1985

SYSTEMATE ALKALINE PHOSPHATASE-67203

K843270 · Em Diagnostic Systems, Inc. · Sep 1984

ALKALINE PHOSPHATASE ASSAY KIT

K842243 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984

KINETIC ALKALINE PHOSPHATASE

K834033 · American Monitor Corp. · Jan 1984

RAICHEM ALKALINE PHOSPHATASE REAGENT

K832463 · Reagents Applications, Inc. · Sep 1983

PARAMAX ALKALINE PHOSPHATASE REAGENT-

K831480 · American Dade · Jun 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K841918

Sigma Diagnostics, Inc.

Mchenry, IL · US

Regulatory profile

164 submissions 164 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active