Cleared Traditional

STASIS - I, II AND III (K060968) - FDA 510(k) Clearance

Also marketed or referenced as:
SERATHAN - A, B INTRIN - EA, SI CALCIUM CHLORIDE 0.02M FIBRINOGEN CONTROL-NORMAL, LOW

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060968 · Wortham Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
403d
Days
Class 2
Risk

K060968 is an FDA 510(k) clearance for the STASIS - I, II AND III. Classified as Plasma, Control, Normal (product code GIZ), Class II - Special Controls.

Submitted by Wortham Laboratories, Inc. (Chattanooga, US). The FDA issued a Cleared decision on May 15, 2007 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Wortham Laboratories, Inc. devices

Submission Details

510(k) Number K060968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2006
Decision Date May 15, 2007
Days to Decision 403 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 113d · This submission: 403d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GIZ Plasma, Control, Normal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.