Cleared Traditional

K813203 - C-TERMINAL PTH RIA TEST KIT

K813203 is the FDA 510(k) clearance for C-TERMINAL PTH RIA TEST KIT by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K813203 · Diagnostic Systems Laboratories, Inc. · Chemistry device
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Dec 1981
Decision
20d
Days
Class 2
Risk

K813203 is an FDA 510(k) clearance for the C-TERMINAL PTH RIA TEST KIT, DSL-1000. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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: 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K813203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1981
Decision Date December 03, 1981
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 50
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K813203.
C-TERMINAL/MID-MOLECULE PARATHYROID -
K843685 · Nichols Institute Diagnostics · Oct 1984
PARATHYROID HORMONE ANALYSIS PRODUCT
K840379 · Nichols Institute Diagnostics · Apr 1984
GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
K822944 · Travenol Laboratories, S.A. · Dec 1982
HORMONE KIT, PARATHYROID
K782010 · Nichols Institute Diagnostics · Jan 1979
COMPLEMENT C3 NEPHELOMETRIC ASSAY
K772249 · Kallestad Laboratories, Inc. · Dec 1977
PTH RIA
K771783 · Nichols Institute Diagnostics · Oct 1977