Cleared Traditional

K970483 - AQUALITE INTACT PTH

K970483 is an FDA 510(k) clearance for AQUALITE INTACT PTH, manufactured by Sealite Sciences, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K970483 · Sealite Sciences, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
63d
Days
Class 2
Risk

K970483 is an FDA 510(k) clearance for the AQUALITE INTACT PTH. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 63 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 Sealite Sciences, Inc. devices

FDA 510(k) Submission Details - K970483

510(k) Number K970483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1997
Decision Date April 14, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

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 73
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K970483.
ELECSYS PARATHYROID HORMONE TEST SYSTEM
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IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp. · Jul 1999
ACTIVE INTACT PTH
K973514 · Diagnostic Systems Laboratories, Inc. · Oct 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · Nichols Institute Diagnostics · Dec 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · Nichols Institute Diagnostics · Sep 1996
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418 · Nichols Institute Diagnostics · Nov 1995