(16 days)
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.
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.
The ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers underwent a study to demonstrate their performance against pre-defined acceptance criteria, primarily focusing on expanded linearity ranges and maintaining accuracy.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | In accordance with EP5-A (NCCLS guidelines) | Good precision for all parameters, "entirely acceptable". |
| Linearity Range (WBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0-120 x 10^3/μL |
| Linearity Range (RBC) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 8.0 x 10^5/μL |
| Linearity Range (HGB) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 24g/dl |
| Linearity Range (HCT) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 67% |
| Linearity Range (PLT with Hgb>2g/dl) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 1,900 x 10^3/μL |
| Linearity Range (PLT with Hgb<2g/dl) | Not explicitly stated as a numerical range acceptance criterion, but the modification covers "extension of the linearity ranges for all parameters." | 0 - 2800 x 10^1/μL |
| Accuracy (Inter-procedural Correlation for WBC & PLT) | Not explicitly stated as a numerical R^2 value acceptance criterion, but the aim was to show "no evidence of significant bias" against a predicate device. | R^2 > 0.95 |
| Accuracy (Inter-procedural Correlation for other parameters) | Not explicitly stated, but implies historical good correlation from previous submissions. | Good correlation demonstrated in previous submissions. |
| Carry-over | < 2.0% for WBC, RBC, HGB, PLT | < 2.0% for WBC, RBC, HGB, PLT |
| Electrical Safety | IEC 1010-1 standard | Complies with IEC 1010-1 standard. |
| Electromagnetic Compatibility (EMC) | EN 61326 standard | Complies with EN 61326 standard. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of samples or patients used for the linearity, precision, accuracy (inter-procedural correlation), or carry-over studies. It refers to "clinical data provided in this submission" and "clinical data of this study."
- Data Provenance: The company is ABX Diagnostics, located in Montpellier, France. The data is thus likely from France, or at least under the purview of ABX Diagnostics. The study appears to be retrospective in the sense that it evaluates the performance of the device and compares it to a predicate, not necessarily a prospective clinical trial with live patient enrollment. However, the term "clinical data" could imply prospective collection for validation purposes. The document doesn't provide enough detail to definitively classify it as solely retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth. For hematology analyzers, ground truth often involves comparison to reference methods or manually performed differential counts by trained laboratory professionals (e.g., medical technologists or hematologists). The document only mentions comparison against the "Abbott CD 4000" as a predicate device for correlation.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given that performance metrics like linearity, precision, and correlation against a predicate device are typically quantitative, a subjective adjudication process by experts is less commonly detailed for such studies compared to, for example, image interpretation tasks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is not applicable. The device is an automated hematology analyzer, not an AI-assisted diagnostic tool that involves human "readers" or interpreters. The study focuses on the standalone performance of the instrument.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done
Yes, a standalone performance study was done. The entire premise of the submission is to demonstrate the performance of the ABX PENTRA 60 and PENTRA 60C+ Hematology Analyzers as fully automated devices, which analyze in-vitro samples without human intervention in the analysis process itself. The "Description" states they are "benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count."
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" or reference for the study was:
- Reference Methods/Standards: For precision, it was based on EP5-A (NCCLS guidelines), which provides methodologies for evaluating precision.
- Predicate Device Comparison: For accuracy (inter-procedural correlation), the ABBOTT CD 4000 (K961439) was used as a reference device. This implies that the measurements from the Abbott CD 4000, a legally marketed and presumably accurate device, served as the comparative ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This is because the device is a laboratory instrument based on established physical and chemical principles (cytochemistry, focused flow impedance, light transmission) rather than a machine learning or AI algorithm that requires a distinct training phase. The software modification mentioned covered linearity extension, which typically involves calibration and validation rather than a "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no mention of a training set for this type of device.
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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
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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).
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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 Hgb<2g/dl (0 - 2800 x 101/uL) are entirely supported by the clinical data provided in this submission.
Accuracy (Inter-procedural Correlation) showed no evidence of significant bias between the PENTRA 60C+ and the Abbott CD 4000 provided good correlation of R2>0.95 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 < 2.0% for WBC, RBC, HGB, PLT.
Conclusions for non clinical and clinical tests :
The clinical studies tests conclude that the safety and effectiveness of the device is not compromised. Clinical testing met all acceptance criteria.
The device meets with the IEC 1010-1 standard of the International Electro-technical Commission on electrical equipment for measurement, control, and laboratory use. As well as the EN 61326 standard for Electromagnetic Compatibility.
All clinical and non clinical tests show appropriate levels of safety and effectiveness.
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Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Tim Lawton Regulatory Affairs Manager ABX Diagnostics Parc Euromedecine Rue du Caducee - BP 7290 34184 Montpellier cedex 4 FRANCE
JAN 3 1 2003
K030144 Trade/Device Name: ABX PENTRA 60 Hematology Analyzer ABX PENTRA 60C+ Hematology Analyzer Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: January 9, 2003 Received: January 15, 2003
Dear Mr. Lawton:
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, 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 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); 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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PENTRA 60 & 60C+
Special 510(k): Device Modification
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
ABX PENTRA 60 Hematology Analyzer ABX PENTRA 60 C+ Hematology Analyzer
Indications For Use:
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.
Josephine Rantzer
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .
(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 CRFR 801.109)
OR
Over-The-Counter Use _
ABX Diagnostics (Horiba Group)
§ 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.”