# K024173: CDS 3-PD Hematology Controls

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Diagnostic Solutions, Inc.
- Decided: Jan 14, 2003 after 27 days
- Product code: JPK (Mixture, Hematology Quality Control)
- Device class: 2
- Regulation: 21 CFR 864.8625
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) Beckman Coulter 4C Plus: named in the summary without a submission number
- (no number) Streck Para 12: named in the summary without a submission number
- (no number) Hematranix Equinox 16: named in the summary without a submission number
- (no number) R&D Systems CBC-3D hematology controls: named in the summary without a submission number

## Recalls of this device
- Feb 24, 2013 · Class II · Z-1436-2014: Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
- Sep 13, 2012 · Class II · Z-0207-2013: A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications a
- Mar 24, 2011 · Class III · Z-0191-2013: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-0
- Mar 24, 2011 · Class III · Z-0190-2013: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-0
- Mar 24, 2011 · Class III · Z-0189-2013: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-0
- Aug 4, 2010 · Class III · Z-0193-2013: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro d
- Aug 4, 2010 · Class III · Z-0194-2013: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro d

## Indications for use
CDS 3-PD Hemarology Controls are intended to scrve as a mcans of verifying the results obtained from a hematology analyzer system, This material applies 1o hematology analyzcr systcms ¢quipped to measure RBC count and size, WBC count and sizc, PLT count and size, total HGB concentration, and calculated parameters HCT, MCH, MCHC, RDW, WBC percent and number for lymphocyte, mononuclear and granulocyte populations. The products are designed to be sampled directly into the analyzer system as a sample specimen with minimal operator intervention.

Source page: https://510kreport.com/device/K024173
Methodology: https://510kreport.com/methodology