Cleared Traditional

K852169 - CHLORIDE REAGENT

K852169 is an FDA 510(k) clearance for CHLORIDE REAGENT, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K852169

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.

CHJ Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (CHJ) and FDA review panel - the closest regulatory comparables to K852169.
CLOROFAST
K863061 · J. D. Assoc. · 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