Cleared Traditional

K970612 - SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY

K970612 is an FDA 510(k) clearance for SEALITE SCIENCES, manufactured by Sealite Sciences, Inc.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K970612 · Sealite Sciences, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1997
Decision
126d
Days
Class 2
Risk

K970612 is an FDA 510(k) clearance for the SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Sealite Sciences, Inc. (Norcross, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sealite Sciences, Inc. devices

FDA 510(k) Submission Details - K970612

510(k) Number K970612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1997
Decision Date June 24, 1997
Days to Decision 126 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 105d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 Immunology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 70
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