Cleared Traditional

K943397 - DSL ACTIVE ALDOSTERONE RIA (DSL 8600)

K943397 is an FDA 510(k) clearance for DSL ACTIVE ALDOSTERONE RIA (DSL 8600), manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code CJM cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K943397 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Feb 1995
Decision
214d
Days
Class 2
Risk

K943397 is an FDA 510(k) clearance for the DSL ACTIVE ALDOSTERONE RIA (DSL 8600). Classified as Radioimmunoassay, Aldosterone (product code CJM), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on February 13, 1995 after a review of 214 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1045 - 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 Diagnostic Systems Laboratories, Inc. devices

FDA 510(k) Submission Details - K943397

510(k) Number K943397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date February 13, 1995
Days to Decision 214 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 88d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJM Device Classification - Class 2, Special Controls

Product Code CJM Radioimmunoassay, Aldosterone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1045
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 - CJM Radioimmunoassay, Aldosterone

All 9
Devices cleared under the same product code (CJM) and FDA review panel - the closest regulatory comparables to K943397.
LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS
K130321 · Diasorin · Apr 2013
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K050784 · Nichols Institute Diagnostics · Jun 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
K032188 · Nichols Institute Diagnostics · Jul 2003
DSL ACTIVE ALDOSTERONE (DSL 8600)
K921205 · Diagnostic Systems Laboratories, Inc. · Jul 1992
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE
K831178 · Diagnostic Products Corp. · May 1983
ALDOCTK-125
K800775 · Sorin Biomedica, Fiat, USA, Inc. · Apr 1980