Cleared Traditional

K040107 - CYTO-CHEX BCT

K040107 is the FDA 510(k) clearance for CYTO-CHEX BCT by Streck Laboratories, Inc.. It is a Class 2 Hematology device (product code JKA) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K040107 · Streck Laboratories, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
189d
Days
Class 2
Risk

K040107 is an FDA 510(k) clearance for the CYTO-CHEX BCT. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (La Vista, US). The FDA issued a Cleared decision on July 27, 2004 after a review of 189 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1675 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Streck Laboratories, Inc. devices

Submission Details

510(k) Number K040107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2004
Decision Date July 27, 2004
Days to Decision 189 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 113d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 115
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K040107.
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BD VACUTAINER SST II PLUS TUBES
K023331 · Becton, Dickinson & CO · Nov 2002
MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
K022875 · Becton, Dickinson & CO · Sep 2002