Cleared Traditional

K840661 - PARAMAX ACID PHOSPHATASE REAGENT

K840661 is the FDA 510(k) clearance for PARAMAX ACID PHOSPHATASE REAGENT by American Dade. It is a Class 2 Hematology device (product code CKB) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K840661 · American Dade · Hematology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 1984

Decision

49d

Days

Class 2

Risk

K840661 is an FDA 510(k) clearance for the PARAMAX ACID PHOSPHATASE REAGENT. Classified as Acid Phosphatase, Naphthyl Phosphate (product code CKB), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1020 - the FDA hematology device 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 American Dade devices

Submission Details

510(k) Number	K840661 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 15, 1984
Decision Date	April 04, 1984
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

64d faster than avg

Panel avg: 113d · This submission: 49d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CKB Acid Phosphatase, Naphthyl Phosphate
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1020

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 Hematology devices follow this clearance model.

Regulatory Peers - CKB Acid Phosphatase, Naphthyl Phosphate

All 16

Devices cleared under the same product code (CKB) and FDA review panel - the closest regulatory comparables to K840661.

ACID PHOSPHATASE (ACP) REAGENT

K863851 · Sigma Diagnostics, Inc. · Oct 1986

ACID PHOSPHATASE PROCEDURE

K861675 · Data Medical Associates, Inc. · May 1986

DATA ZYME ACID PHOSPHATASE PROCEDURE

K850902 · Data Medical Associates, Inc. · Mar 1985

RAICHEM ACID PHASPHATASE REAGENT

K831834 · Reagents Applications, Inc. · Aug 1983

BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA

K823087 · Boehringer Mannheim Corp. · Nov 1982

SPINCHEM ACID PHOSPHATASE REAGENT

K821674 · Smithkline Diagnostics, Inc. · Jun 1982

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 K840661

American Dade

Mchenry, IL · US

Regulatory profile

149 submissions 149 cleared

100% clearance rate · Active in Hematology

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