Cleared Traditional

K902530 - SPECTROLYSE ATIII KIT

K902530 is an FDA 510(k) clearance for SPECTROLYSE ATIII KIT, manufactured by Biopool AB. The device is a Class 2 Hematology device with product code JBQ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K902530 · Biopool AB · Hematology device
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Aug 1990
Decision
65d
Days
Class 2
Risk

K902530 is an FDA 510(k) clearance for the SPECTROLYSE ATIII KIT. Classified as Antithrombin Iii Quantitation (product code JBQ), Class II - Special Controls.

Submitted by Biopool AB (Ontario, L7l 6b8, CA). The FDA issued a Cleared decision on August 9, 1990 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7060 - 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: 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 Biopool AB devices

FDA 510(k) Submission Details - K902530

510(k) Number K902530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1990
Decision Date August 09, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 113d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JBQ Device Classification - Class 2, Special Controls

Product Code JBQ Antithrombin Iii Quantitation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7060
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.

Regulatory Peers - JBQ Antithrombin Iii Quantitation

All 48
Devices cleared under the same product code (JBQ) and FDA review panel - the closest regulatory comparables to K902530.
ANTITHROMBIN III CHROMOGENIC ASSAY
K936196 · Baxter Diagnostics, Inc. · May 1994
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667 · The Binding Site, Ltd. · Jan 1992
LIATEST(R) AT III TEST KIT
K905110 · American Bioproducts Co. · Jan 1991
BECKMAN ANTITHROMBIN III REAGENT KIT
K901977 · Beckman Instruments, Inc. · Aug 1990
ORTHOKROME* ANTITHROMBIN
K900400 · Ortho Diagnostic Systems, Inc. · Mar 1990
ACTICHROME ATIII KIT
K893608 · American Diagnostic Corp. · Jun 1989