← Product Code [GKZ](/productcode/GKZ) · K030144 # MODIFICATION TO PENTRA 60 AND PENTRA 60C+ (K030144) _Abx Diagnostics · GKZ · Jan 31, 2003 · Hematology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K030144 ## Device Facts - **Applicant:** Abx Diagnostics - **Product Code:** [GKZ](/productcode/GKZ.md) - **Decision Date:** Jan 31, 2003 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## 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. ## Device Story Benchtop clinical laboratory instruments; analyze whole blood samples for complete blood count (CBC) and 5-part leucocyte differential. Utilize cytochemistry, focused flow impedance, and halogen light transmission. PENTRA 60 features integrated keyboard/LCD; PENTRA 60C+ connects to dedicated workstation with user interface software. Microprocessor-controlled; provides automated hematological analysis. Used by laboratory personnel to assist in clinical diagnosis. Software modification extends linearity ranges for parameters. Output enables healthcare providers to assess patient hematological status. ## Clinical Evidence Bench testing performed per NCCLS EP5-A guidelines. Linearity validated for WBC, RBC, HGB, HCT, and PLT. Accuracy demonstrated via inter-procedural correlation with Abbott CD 4000 (R2 > 0.95 for WBC and PLT). Carry-over measured at < 2.0%. Compliance with IEC 1010-1 and EN 61326 standards confirmed. ## Technological Characteristics Benchtop hematology analyzer; cytochemistry, focused flow impedance, and halogen light transmission sensing. Microprocessor-controlled. PENTRA 60 is standalone; PENTRA 60C+ is workstation-connected. Complies with IEC 1010-1 (electrical safety) and EN 61326 (EMC). ## Regulatory 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 - PENTRA 60 ([K992511](/device/K992511.md)) - PENTRA 60C+ ([K003677](/device/K003677.md)) ## Reference Devices - ABBOTT CD 4000 ([K961439](/device/K961439.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 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. {3}------------------------------------------------ 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 a bird or eagle with three lines representing its wings or feathers. 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. {4}------------------------------------------------ Page 2 - 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for ABX Horiba Diagnostics. The logo features a stylized letter "A" with a vertical line extending upwards from the center. Below the "A" is the word "HORIBA" in a smaller, sans-serif font. Underneath the entire logo, the word "DIAGNOSTICS" is printed in block letters. # 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) --- **Source:** [https://fda-staging.innolitics.com/device/K030144](https://fda-staging.innolitics.com/device/K030144) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com