Cleared Traditional

K914429 - DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)

K914429 is an FDA 510(k) clearance for DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL..., manufactured by Diagnostic Systems Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JKR cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K914429 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Jan 1992
Decision
103d
Days
Class 2
Risk

K914429 is an FDA 510(k) clearance for the DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200). Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1140 - 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 - K914429

510(k) Number K914429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date January 15, 1992
Days to Decision 103 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
15d slower than avg
Panel avg: 88d · This submission: 103d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKR Device Classification - Class 2, Special Controls

Product Code JKR Radioimmunoassay, Calcitonin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1140
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 - JKR Radioimmunoassay, Calcitonin

All 15
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K914429.
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · Scantibodies Laboratory, Inc. · May 1996
CALCITONIN IMMUNOASSAY KIT
K945961 · Nichols Institute Diagnostics · Nov 1995
MODIFIED CALCITONIN RIA KIT DSL #1200
K874087 · Diagnostic Systems Laboratories, Inc. · Feb 1988
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · Diagnostic Products Corp. · Jun 1986
CALCITONIN RIA KIT
K854240 · Diagnostic Systems Laboratories, Inc. · Nov 1985