(16 days)
No
The summary describes a standard automated hematology analyzer using established principles like impedance and light transmission. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The technology described is microprocessor-controlled but not indicative of AI/ML.
No
This device is a hematology analyzer used for in vitro diagnostic testing, which means it analyzes samples to provide diagnostic information, not to treat or alleviate a medical condition.
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 benchtop clinical laboratory instrument that analyzes whole blood samples using physical principles like cytochemistry, focused flow impedance, and light transmission, indicating it is a hardware device with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens."
This statement clearly indicates that the device is intended for diagnostic testing performed on biological samples (whole blood) outside of the body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ABX PENTRA 60 & PENTRA 60C+ are fully automated (microprocessor controlled) multi-parameter hematology analyzer intended for in in-vitro diagnostic use in the clinical laboratory environment.
The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens.
The ABX PENTRA 60 and 60C+ Hematology Analyzer are able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
Product codes
GKZ
Device Description
The ABX PENTRA 60 & PENTRA 60C+ are benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source.
The PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.
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
Clinical laboratory environment.
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
The data presented in this 510K Pre-market Notification demonstrate good precision in accordance with EP5-A (NCCLS guidelines) and is entirely acceptable for all parameters.
The linearity claim for the parameters WBC (0-120 x 103/μL), RBC (0 - 8.0 x 105/μL), HGB(0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/dl (0 - 1,900 x 103/μL) and PLT with Hgb0.95 for WBC & PLT parameters. All other parameters demonstrated in previous submissions good correlation.
No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a Carry-over claim of 2g/dl (0 - 1,900 x 103/μL) and PLT with Hgb0.95 for WBC & PLT parameters. All other parameters demonstrated in previous submissions good correlation.
No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a Carry-over claim of 2g/dl (0 - 1,900 x 103/μL) and PLT with Hgb 0.95 for WBC & PLT parameters.
Carry-over claim:
§ 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
Image /page/0/Picture/0 description: The image is a logo for ABX Horiba Diagnostics. The logo is black and white and features the letters "ABX" in a stylized font. Below the letters, the word "HORIBA" is written in a smaller, sans-serif font. Below that, the word "DIAGNOSTICS" is written in a larger, sans-serif font.
Premarket Notification [510(k)] Summary
JAN 3 1 2003
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is: K030144
Company: ABX Diagnostics
Parc Euromédecine
Rue du Caducée – BP 7290
34184 Montpellier cedex 4
FRANCE
Telephone: + (33) 4 67 14 73 20
Fax: + (33) 4 67 14 15 17
Contact Person: Tim Lawton (tlawton@fr.abx.fr)
Date Prepared: 10th January, 2003
Device Name:
Trade/Proprietary Names: ABX PENTRA 60 Hematology Analyzer
ABX PENTRA 60C+ Hematology Analyzer
Common or Usual Name: Automated cell counter and
Automated differential cell counter
Device Class Class II : Special Controls Guidance Document
Classification Name: Automated cell counter (§864.5200) and
Automated differential cell counter (§864.5220)
Product Code: GKZ
1
Substantial Equivalence:
The ABX PENTRA 60 & PENTRA 60C+ are based on the same fundamental technology as the predicate devices cleared to market under K992511 and K003677.
A software modification covers the extension of the linearity ranges for all parameters to place, having no effect on the fundamental scientific technology
The use of a predicate device (ABBOTT CD 4000 : K961439) was used to demonstrate the clinical correlation for some parameters.
Description:
The ABX PENTRA 60 & PENTRA 60C+ are benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source.
The PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.
Intended Use :
The ABX PENTRA 60 & PENTRA 60C+ are fully automated (microprocessor controlled) multi-parameter hematology analyzer intended for in in-vitro diagnostic use in the clinical laboratory environment.
Compared to the previous 510k submissions, there is no change to the intended use
Determination of substantial equivalence :
The ABX PENTRA 60 & PENTRA 60C+ are substantially equivalent to the already cleared devices PENTRA 60 (K992511) and PENTRA 60C+ (K003677) with respect to the indications for use, the hematological parameters for complete blood count and differential leucocyte count, and the principles of operation (fundamental scientific technology).
2
Discussion of Performance Data:
The studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines.
The data presented in this 510K Pre-market Notification demonstrate good precision in accordance with EP5-A (NCCLS guidelines) and is entirely acceptable for all parameters.
The linearity claim for the parameters WBC (0-120 x 103/μL), RBC (0 - 8.0 x 105/μL), HGB(0 - 24g/dl), HCT (0 - 67%), PLT with Hgb>2g/dl (0 - 1,900 x 103/μL) and PLT with Hgb0.95 for WBC & PLT parameters. All other parameters demonstrated in previous submissions good correlation.
No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a Carry-over claim of