Cleared Traditional

K943268 - SCS-1000 (SYSMEX CALIBRATOR SYSTEM)

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

K943268 · Streck Laboratories, Inc. · Hematology device
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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

Submission Details

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.

Device Classification

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