Cleared Traditional

K943268 - SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

K943268 is an FDA 510(k) clearance for SCS-1000 (SYSMEX CALIBRATOR SYSTEM), manufactured by Streck Laboratories, Inc.. The device is a Class 2 Hematology device with product code KSA cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K943268 · Streck Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
161d
Days
Class 2
Risk

K943268 is an FDA 510(k) clearance for the SCS-1000 (SYSMEX CALIBRATOR SYSTEM). Classified as Calibrator For Red-cell And White-cell Counting (product code KSA), Class II - Special Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 161 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8185 - 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 - K943268

510(k) Number K943268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1994
Decision Date December 15, 1994
Days to Decision 161 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
48d slower than avg
Panel avg: 113d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSA Device Classification - Class 2, Special Controls

Product Code KSA Calibrator For Red-cell And White-cell Counting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8185
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 - KSA Calibrator For Red-cell And White-cell Counting

Devices cleared under the same product code (KSA) and FDA review panel - the closest regulatory comparables to K943268.
CBC-CAL(TM) PLUS HEMATOLOGY CALIBRATOR/MULTIPLE
K897060 · R&D Systems, Inc. · Jan 1990
TECH-CAL(TM)/MULTIPLE
K881161 · R&D Systems, Inc. · May 1988
H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS
K864664 · Technicon Instruments Corp. · Feb 1987
CBC-CAL/MULTIPLE
K854823 · R&D Systems, Inc. · Feb 1986
HEMOTOLOGY CALIBRATOR
K813530 · American Dade · Feb 1982
HEMATOLOGY CALIBRATOR S-CAL
K813375 · Coulter Electronics, Inc. · Feb 1982