(188 days)
Not Found
No
The description focuses on standard hematology analyzer technologies (impedance, photometry, flow cytometry) and software features like data storage and connectivity. There is no mention of AI or ML algorithms for analysis or interpretation.
No
Explanation: The device is an in-vitro diagnostic hematology analyzer used to count blood parameters, not to treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for in-vitro-diagnostic use" and "is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges." This directly indicates its role in diagnosing conditions.
No
The device description clearly outlines hardware components such as a laser-based optical measurement system, impedance method for cell counting, photometric measurement technology, a touch screen display, USB connections, and optional autosampler. While it has a software system, it is integral to the operation of the physical analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories..."
This statement directly identifies the device as intended for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The 'Abacus 5' is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical measurement technology. The 'Abacus 5' analyzer uses the impedance method for measurement of leukocytes (WBC), erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the hemoglobin (HGB) content of red blood cells is accomplished by photometric measurement technology. Five part leukocyte differential (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using optical laser-based flow cytometric technology. A vivid color touch screen display is featured with an intuitive, informative, and attractive user interface. A START button allows one-touch operation for ease of use. The 'Abacus 5' analyzer's unique software system supports the use of many commonly used external printers with its USB connections. The 'Abacus 5' internal database is capable of storing 100,000 patient, QC, and calibration result records including flags and graphical scatter diagrams and histograms. The system software is field-upgradeable to ensure up-to-date operation. An automatic optional Autosampler is available (sold separately) for automated processing of up to 100 sample tubes for increased laboratory efficiency. The 'Abacus 5' features advanced Ethernet LIS connectivity using the HL7 protocol in addition to standard serial interfaces, providing the clinical laboratory with flexible connectivity options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All required software and system verification and validation procedures have been executed and analyzed per FDA recommended standards and the Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells. All risk and hazard analysis have been performed and documented per ISO 14971 guidelines. All performance and accuracy summary data and conclusions can be referenced in document # A5-05-0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2, that is included with this submission. All performance and accuracy data and data analysis in this submission support and substantiate equivalence to the selected predicate device. (Abbott CELL-DYN 3700, K991605).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Abbott CELL-DYN® 3700 (K991605)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”
0
MAR 2 7 2012
510(k) Summary
| Submitter | Diatron US Inc.
14026 W. 107th Street
Lenexa, Kansas 66215-2005 | | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Michael Switzer, Director, Quality Assurance
P: 954-790-9550
F: 954-827-2644
E: mike.switzer@diatron.com | | |
| Date Prepared | March 19,2012 | | |
| Trade Name | Abacus 5, Automated Hematology Analyzer | | |
| Classification | Class II
Automated Differential Cell Counter
21 CFR §864.5220 | | |
| Product Code | GKZ | | |
| Predicate
Device(s) | The subject device is equivalent to the following device: Abbott CELL-DYN® 3700 (K991605) | | |
| Device
Description | The 'Abacus 5' is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical
laboratories. It provides precise and accurate 5-part differential measurement using a laser based optical
measurement technology. The 'Abacus 5' analyzer uses the impedance method for measurement of
leukocytes (WBC), erythrocytes (RBC) and platelet (PLT) concentrations. Measurement of the
hemoglobin (HGB) content of red blood cells is accomplished by photometric measurement technology.
Five part leukocyte differential (LYM%, MON%, NEU%, EOS%, BAS%) is accomplished using optical
laser-based flow cytometric technology. A vivid color touch screen display is featured with an intuitive,
informative, and attractive user interface. A START button allows one-touch operation for ease of use.
The 'Abacus 5' analyzer's unique software system supports the use of many commonly used external
printers with its USB connections. The 'Abacus 5' internal database is capable of storing 100,000
patient, QC, and calibration result records including flags and graphical scatter diagrams and
histograms. The system software is field-upgradeable to ensure up-to-date operation. An automatic
optional Autosampler is available (sold separately) for automated processing of up to 100 sample tubes
for increased laboratory efficiency. The 'Abacus 5' features advanced Ethernet LIS connectivity using
the HL7 protocol in addition to standard serial interfaces, providing the clinical laboratory with flexible
connectivity options. | | |
| Intended Use | The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer
designed for in-vitro -diagnostic use in clinical laboratories for enumeration of the following parameters in
K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%,
NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and
MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within
and outside of established reference ranges. | | |
| Functional and
Safety Testing | To verify that device design met it's functional and performance requirements, a representative sample
of the device underwent software and system verification and validation testing, in accordance with
Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell
Counters for Immature or Abnormal Blood cells. A risk and hazard analysis was performed per ISO
14971. | | |
| Substantial
Equivalence:
Similarities | Item | Diatron Abacus 5 | Abbott CELL-DYN 3700 |
| | Indication for Use
Statement | The Diatron Abacus 5 System is a quantitative
multi-parameter automated hematology
analyzer designed for in-vitro -diagnostic use in
clinical laboratories for enumeration of the
following parameters in K3EDTA anti-coagulated
venous whole blood samples: WBC, LYM%,
LYM#, MON%, MON#, NEU%, NEU%, EOS%,
EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV,
MCH, MCHC, RDWcv, RDWsd, PLT and MPV.
The Diatron Abacus 5 is indicated for use to
identify patients with hematologic parameters
within and outside of established reference
ranges. | The Diatron Abacus 5 System
is a quantitative multi-
parameter automated
hematology analyzer designed
for in-vitro -diagnostic use in
clinical laboratories for
enumeration of the following
parameters in K3EDTA anti-
coagulated venous whole blood
samples: WBC, LYM%, LYM#,
MON%, MON#, NEU%, NEU#,
EOS%, EOS#, BAS%, BAS#,
RBC, HGB, HCT, MCV, MCH,
MCHC, RDWcv, RDWsd, PLT
and MPV. The Diatron Abacus
5 is indicated for use to identify
patients with hematologic
parameters within and outside |
| | | | |
| | Sampling Mechanisms | - manual sampling (one sample at a time )
- autosampler sampling
- cap piercing function for closed tubes
- interchangeable sample adapters for different
tube types - automatic aspiration of specimen and
presentation for automated processing | of established reference ranges.
Same |
| | Sample Processing | Open vial mode, closed vial mode and
autosampler | Same |
| | Sample ID | Manual and Barcode | Same |
| | Methodology | WBC = Impedance
NEU = Calculated
NEU% = Optical
LYM = Calculated
LYM% = Optical
MON = Calculated
MON% = Optical
EOS = Calculated
EOS% = Optical
BAS = Calculated
BAS% = Optical
RBC = Impedance
HGB = Photometric
HCT = Calculated
MCV = Derived
MCH = Calculated
MCHC = Calculated
RDWcv = Derived
RDWsd = Calculated
PLT = Impedance
MPV = Derived | Same |
| | WBC Differential | NEU%, LYM%, MON%, EOS%, BAS% | Same |
| | Sample Type | K3 EDTA anticoagulated venous whole blood | Same |
| | Parameters | WBC, NEU, NEU%, LYM, LYM%, MON,
MON%. EOS, EOS%, BAS, BAS%, RBC, HGB,
HCT, MCV, MCH, MCHC, RDWcv, RDWsd,
PLT, MPV | Same |
| | QC | Maintains QC files, generates Levey-Jennings
Charts | Same |
| | Calibration | Manual calibration and SW supported
calibration in automatic mode | Same |
| | Flags/Alerts | Dispersional data alerts, suspect parameter
messages and suspect population flags to
assist in data review | Same |
| | Barcode Reader | Built-in barcode readers in the autosampler | Same |
| | External Printing | External printing capabilities with a compatible
printer | Same |
| | Data Input/Ouput | Accept input from the keyboard and send data
output to the video screen, hard drive and
printer | Same |
| | Microprocessors | Use microprocessors for systems control, data
acquisition and data analysis | Same |
| Substantial
Equivalence:
Differences | Item | Diatron Abacus 5 | Abbott CELL-DYN 3700 |
| | Methodology | Uses the impedance method for WBC; the
RDWsd is calculated | Uses simultaneous optical and
impedance measurements for WBC;
the RDWsd is derived |
| | Parameters | Measures RDWcv; does not measure
RETC, %RETC, IRF | Does not measure RDWcv; measures
RETC, %RETC, IRF |
| | Throughput | 60 samples per hour | 90 samples per hour |
| | Sample Aspiration | Open Vial Mode - 110µl | Open Vial Mode - 130 µl |
| | Volume | Closed Vial Mode - 110 µl | Closed Vial Mode - 240 µl |
| | | Autosampling - 110 µl | Autosampling - 355 µl |
| | Reagents | Manufactured specifically for the Abacus 5 | Manufactured specifically for the Cell-
Dyn 3700; also has a specific RETC |
| Calibrator and
Controls | Recommends R&D Systems Calibrator
and Controls | Abbott CELL-DYN Calibrator and
Controls | |
| Data Storage | 100,000 records including flags, scatter
and histograms, QC records | 10,000 records including flags, scatter
and histograms | |
| Interface to On-line
LIS | Bidirectional RS232 or Ethernet interfacing | Bidirectional RS232 interfacing | |
| Keyboard | Optional keyboard, connected through
PS/2 or USB | Comes with keyboard connected
through PS/2 | |
| Barcode Reader | Optional manual barcode reader
connected via USB port | Manual barcode entry via keyboard | |
| Peripheral Ports | 1- PS/2 mouse port | 1- VGA port | |
| | 1- PS/2 keyboard port | 1- Audio port | |
| | 2- COM ports for LIS | 1- USB port | |
| | 1- DVI-D port (unused) | | |
| | 1- VGA port (unused) | | |
| | 2- RJ45 Ethernet port for LIS | | |
| | 4- USB 2.0 ports
3- Audio jacks | | |
| Performance | | | All required software and system verification and validation procedures have been executed and
analyzed per FDA recommended standards and the Class II Special Controls Guidance Document:
Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells.
All risk and hazard analysis have been performed and documented per ISO 14971 guidelines. All
performance and accuracy summary data and conclusions can be referenced in document # A5-05-
0020-02, Validation Report of Abacus 5 Hematology Instrument, Revision 2, that is included with this
submission. All performance and accuracy data and data analysis in this submission support and.
substantiate equivalence to the selected predicate device.(Abbott CELL-DYN 3700, K991605). |
| Conclusion | | | Diatron concludes, based on all information submitted and discussed in this submission and in this
summary, that the Diatron, Abacus 5 is substantially equivalent to the tested predicate device and has
demonstrated to be a safe and effective product to be marketed in the United States. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Diatron US, Inc. c/o Mr. Michael Switzer Director, Quality Assurance 14026 W. 107th Street Lenexa, KS 66215
Re: K112755
Trade/Device Name: Abacus 5 Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: February 15, 2012 Received: February 17, 2012
Dear Mr. Switzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
MAR 2 7 2012
4
Page 2 - Mr. Michael Switzer
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
$\theta^2$ Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K112755
Device Name: Abacus 5
Indications for Use:
The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PLT and MPV. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112755.
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