Cleared Traditional

K080552 - CYTO-CHEX BCT

K080552 is an FDA 510(k) clearance for CYTO-CHEX BCT, manufactured by Streck. The device is a Class 2 Hematology device with product code GIM cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K080552 · Streck · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
154d
Days
Class 2
Risk

K080552 is an FDA 510(k) clearance for the CYTO-CHEX BCT. Classified as Tubes, Vacuum Sample, With Anticoagulant (product code GIM), Class II - Special Controls.

Submitted by Streck (La Vista, US). The FDA issued a Cleared decision on July 31, 2008 after a review of 154 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 devices

FDA 510(k) Submission Details - K080552

510(k) Number K080552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2008
Decision Date July 31, 2008
Days to Decision 154 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
41d slower than avg
Panel avg: 113d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIM Device Classification - Class 2, Special Controls

Product Code GIM Tubes, Vacuum Sample, With Anticoagulant
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 - GIM Tubes, Vacuum Sample, With Anticoagulant

All 29
Devices cleared under the same product code (GIM) and FDA review panel - the closest regulatory comparables to K080552.
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
K230493 · Becton, Dickinson and Company · Nov 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
K213670 · Becton, Dickinson and Company · Aug 2023
TransFix/EDTA Vacuum Blood Collection Tubes
K162723 · Caltag Medsystems, Ltd. · Jun 2017
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · Becton Dickinson Vacutainer Systems · Jun 1997
GREINER VACUETTE BLOOD COLLECTION TUBE
K971221 · Greiner America, Inc. · May 1997
VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM
K945458 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1995