(69 days)
BAKER SYSTEM 9110⁺ PLUS
Not Found
No
The description focuses on standard hematology analysis techniques (cytochemistry, impedance, light transmission) and mentions microprocessor control and automated features, but there is no mention of AI, ML, or related concepts.
No
The device is described as an in vitro diagnostic (IVD) analyzer used for testing whole blood specimens to provide complete blood count data, not for direct therapeutic intervention on a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for the in vitro diagnostic testing of whole blood specimens".
No
The device description clearly states it is a "bench top clinical laboratory instrument" that uses physical principles like "cytochemistry, focused flow impedance, and light transmission technology" to analyze blood samples. This indicates it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates."
This statement clearly indicates that the device is intended for diagnostic testing performed on biological samples (whole blood specimens or blood cell concentrates) outside of the living body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
Product codes
GKZ
Device Description
The ABX MICROS 60 Hematology Analyzer is a bench top clinical laboratory instrument which analyzes in vitro samples of whole blood to provide complete blood count data using principles of cytochemistry, focused flow impedance, and light transmission technology. The system is equipped with automatic calibration; Automated smart cards based for: calibration, QC with 93 multiple range files and memory with 60 erasable results.
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
Not Found
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)
Data provided in the 510(k) application demonstrate that within-run, between-run, and between-day precision for the ABX MICROS 60 is acceptable, with the highest CV (3.0%) being obtained for the high level control tested 10 times in succession on a single day, (B) the assay is quite linear from 250 to 5000 x 103/μL, (C) results from the ABX MICROS 60 assay are highly correlated with those derived from the Baker System 9110+ PLUS, although the values tend to be somewhat lower, and (D) there is no carry-over when samples having low platelet counts are assayed after those with substantially higher counts.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BAKER SYSTEM 9110⁺ PLUS Hematology Analyzer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
0
KD14203
Premarket Notification [510(k)] Summary SECTION B
- ABX Diagnostics, Inc. Company: 34 Bunsen Drive Irvine, CA 92618 Phone: (949) 453-0500 FAX: (949) 453-0600 Date Prepared: December 7, 2001
Contact Person: Tom M. Phillips
Date of Preparation: December 19, 2001
| Trade/Proprietary Name: | ABX MICROS 60 Hematology Analyzer |
|---|---|
| Common or Usual Name: | Automated cell counter and |
| Automated differential cell counter | |
| Classification Name: | Automated cell counter (864.5200) and |
| Automated differential cell counter (864.5220) | |
| Product Code: | GKZ (Hematology Analyzer) |
| Substantial Equivalence: | The ABX MICROS 60 is substantially equivalent to the |
| BAKER SYSTEM 9110⁺ PLUS Hematology Analyzer | |
| Description: | The ABX MICROS 60 Hematology Analyzer is a |
| bench top clinical laboratory instrument which analyzes | |
| in vitro samples of whole blood to provide complete | |
| blood count data using principles of cytochemistry, | |
| focused flow impedance, and light transmission | |
| technology. The system is equipped with automatic | |
| calibration; Automated smart cards based for: | |
| calibration, QC with 93 multiple range files and | |
| memory with 60 erasable results. | |
| Indication for Use: | The ABX MICROS 60 Hematology Analyzer is a fully |
| automated (microprocessor controlled) hematology | |
| analyzer used for the in vitro diagnostic testing of whole | |
| blood specimens or blood cell concentrates. It operates in | |
| complete blood count (CBC) mode. |
Comparison to the Predicate Device:
The ABX MICROS 60 Hematology Analyzer is equivalent to the BAKER SYSTEM 9110* PLUS Hematology Analyzer; both instruments are fully automated hematology analyzers using whole blood to measure WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, and MPV. The ABX MICROS 60 also measures differential
1
counts whereas the BAKER SYSTEM 9110* PLUS does not.
Discussion of Performance Data:
Data provided in the 510(k) application demonstrate that within-run, between-run, and between-day precision for the ABX MICROS 60 is acceptable, with the highest CV (3.0%) being obtained for the high level control tested 10 times in succession on a single day, (B) the assay is quite linear from 250 to 5000 x 103/μL, (C) results from the ABX MICROS 60 assay are highly correlated with those derived from the Baker System 9110+ PLUS, although the values tend to be somewhat lower, and (D) there is no carry-over when samples having low platelet counts are assayed after those with substantially higher counts.
The ABX MICROS 60 Hematology Analyzer provides Conclusion: reliable data when used to quantitate the number of platelets in preparations having relatively high concentrations of this analyte (250 - 5000 103/µL range).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - IRA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - IRA" arranged around the perimeter of the circle. Inside the circle is a stylized image of what appears to be an eagle or other bird with three lines representing the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 8 2002
Mr. Tom M. Phillips Manager of Regulatory Affairs ABX Diagnostics, Inc. 34 Bunsen Drive Irvine, CA 92618
Re: K014203
Trade/Device Name: ABX Micros 60 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: December 19, 2001 Received: December 21, 2001
Dear Mr. Phillips:
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 10 more 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 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 Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
K014203 510(k) Number (if known):
Device Name: ABX MICROS 60 Hematology Analyzer
Indications For Use:
The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor The ADA MICROD ov analyzer used for the in vitro diagnostic testing of whole Controlled) nomatorogy and your accurates. It operates in complete blood count (CBC) mode.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
OR
Over-The-Counter Use
Josephine Bautista
510(k) Number K014203