Cleared Traditional

K040107 - CYTO-CHEX BCT

K040107 is an FDA 510(k) clearance for CYTO-CHEX BCT, manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with 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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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

FDA 510(k) Submission Details - K040107

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.

JKA Device Classification - Class 2, Special Controls

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 164
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K040107.
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE
K060364 · Teco Diagnostics · Jun 2006
SAFETY NEEDLE
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SAFEPICO
K043143 · Radiometer Medical Aps · Apr 2005
VENOJECT LUER ADAPTER
K041358 · Terumo Europe N.V. · May 2004
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381
K041071 · Becton, Dickinson & CO · May 2004
BD VACUTAINER SST II PLUS TUBES
K023331 · Becton, Dickinson & CO · Nov 2002