CELL-DYN Emerald 22 AL System

K190294 · Abbott Laboratories · GKZ · Mar 15, 2019 · Hematology

Device Facts

• Record ID: K190294
• Device Name: CELL-DYN Emerald 22 AL System
• Applicant: Abbott Laboratories
• Product Code: GKZ · Hematology
• Decision Date: Mar 15, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The CELL-DYN Emerald 22 System is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories.

Device Story

CELL-DYN Emerald 22 System; automated hematology analyzer; performs quantitative blood analysis and leukocyte differential counting. Modification adds sample autoloader for automated sample processing; includes rack transfer, mixing, and unloading. Modifications involve open/close tube operation, sampling module, operating system, and system board. Used in clinical laboratories; operated by laboratory personnel. Output provides hematological data for clinical decision-making regarding patient blood health.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical design verification and analytical performance testing, including background, carryover, linearity, short/long-term imprecision, method comparison, blood tube type study, mode-to-mode equivalency, and clogging rate analysis.

Technological Characteristics

Bench-top analyzer; electrical impedance, absorption spectrophotometry (555nm LED), and optical flow cytometry (455nm LED). Autoloader module for 50-tube capacity; trocar needle for cap piercing. CPU: Phytec Freescale i.MX27, ARM926EJ, 400MHz+. Connectivity: USB ports for external storage/peripherals, LIS integration. Software: OSE Delta operating system. Dimensions: 16.1" x 19.7" x 17.0".

Indications for Use

Indicated for use in clinical laboratories to identify patients with hematologic parameters within and outside of established reference ranges using K2EDTA anticoagulated whole blood.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• CELL-DYN Emerald 22 system (K110381)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION MEMORANDUM

510(k) Number: K190294

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device. CELL-DYN Emerald 22 System; K110381.
2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of a sample autoloader to automate sample processing by transferring, mixing, and unloading sample racks. Modifications made due to the addition of the autoloader include: open/close tube operation, sampling module, operating system and the system board.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, and physical characteristics are located in the 510(k) Summary.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.