Cleared Traditional

K852169 - CHLORIDE REAGENT

K852169 is the FDA 510(k) clearance for CHLORIDE REAGENT by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code CHJ) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K852169 · Pointe Scientific, Inc., · Chemistry device
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Aug 1985
Decision
93d
Days
Class 2
Risk

K852169 is an FDA 510(k) clearance for the CHLORIDE REAGENT. Classified as Mercuric Thiocyanate, Colorimetry, Chloride (product code CHJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Detroit, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Pointe Scientific, Inc., devices

Submission Details

510(k) Number K852169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date August 21, 1985
Days to Decision 93 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
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHJ Mercuric Thiocyanate, Colorimetry, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 - CHJ Mercuric Thiocyanate, Colorimetry, Chloride

All 39
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K852169.
RAICHEM(TM) CHLORIDE REAGENT
K863620 · Reagents Applications, Inc. · Sep 1986
CHLORIDE PROCEDURE
K861674 · Data Medical Associates, Inc. · Jul 1986
AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271
K860662 · Amresco, Inc. · Mar 1986
CHLORIDE ASSAY KIT
K852058 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1985
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
K850334 · Roche Diagnostic Systems, Inc. · Mar 1985
SCLAVO CHLORIDE TEST
K843740 · Sclavo, Inc. · Oct 1984