(109 days)
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No
The summary describes a standard automated differential cell counter and does not mention any AI or ML technologies. The performance studies focus on basic functional and software verification, not on the performance of an AI/ML algorithm.
No
This device is an in vitro diagnostic (IVD) method used to measure components in whole-blood samples. It is used for diagnosis and monitoring, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic method" and is used to "identify and classify one or more of the formed elements of blood." This aligns with the definition of a diagnostic device.
No
The device description and performance studies clearly indicate this is a hardware device (Automated differential cell counter) that performs physical measurements on blood samples, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use statement explicitly states that the Chempaq XBC Analyzer is an "in vitro diagnostic method" and describes its use for quantitative determination of blood components in whole-blood samples. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") in whole-blood samples (finger stick or venous sample).
The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.
Product codes
GKZ
Device Description
Automated differential cell counter
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories, and for point-of-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were done to demonstrate correct function of:
Quality Control Cassette (QCC) for testing of the PAQ electrical connection and Hemoglobin photometric function in the QCC mode.
Liquid Quality Controls (LQCs) with White Blood Cell (WBC) PAQs with the Analyzer in the LQC mode
Linearity materials with the Analyzer in the Linearity mode using WBC PAQs.
Associated print-out of LQC, QCC, Linearity, and patient ID (from bar code scanner).
Bench testing was done to show the Analyzer detected mismatches such as inserting the WBC PAQ in the QCC mode or the QC Cassette in the WBC mode.
Bench performance testing was done to show that all WBC functionality was uncompromised by the modifications.
Software verification and validation was done on all added functionality including code reviews and direct testing of software functionality (e.g. that correct information was shown on the Analyzer LCD depending on the mode selected).
Results of testing demonstrate that the modifications to the Chempaq XBC Analyzer did not modify white blood cell or hemoglobin measurement functionality, that the added functionality performs as intended, and that potential risks (such as mismatching of PAQ/QCC and test mode) have been mitigated by software changes to detect such mismatches to deliver an error message and prevent reporting of results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Chempaq XBC Analyzer
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
15090013
APR 2 1 2009
5 510(k) Summary
سمبر مار
| 510(k) Summary | |
|---|---|
| Submitter: | Chempaq A/S |
| Hirsemarken 1 B | |
| 3520 Farum | |
| Denmark | |
| Contact Person: | Lone Hoffensets |
| Quality Assurance Manager | |
| Chempaq A/S | |
| Hirsemarken 1 B | |
| 3520 Farum | |
| Denmark | |
| Phone 011-45 44390500 | |
| Fax 011-45 44390539 | |
| Email: lh@chempaq.com | |
| Date Prepared: | December 17, 2008 |
| Trade Name: | Chempaq XBC Analyzer |
| Classification: | 21 CFR 864.5220 |
| Product Codes: | GKZ |
| Predicate Device: | Chempaq XBC Analyzer |
| Device | |
| Description: | Automated differential cell counter |
| Intended Use: | The Chempaq XBC Analyzer is an in vitro diagnostic method |
| intended for the quantitative determination of the concentration | |
| of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes | |
| ("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") in | |
| whole-blood samples (finger stick or venous sample). | |
| The Chempaq XBC Analyzer is indicated for use in: clinical | |
| laboratories, and for point-of-care hematology determinations in | |
| doctors' offices or by healthcare professionals in hospital settings | |
| to identify and classify one or more of the formed elements of | |
| blood. | |
| 510(k) Summary | |
| Functional and | |
| Safety Testing: | Chempaq XBC Analyzer uses a single-use, reagent cassette |
| (cartridge) called a "PAQ" which designates "Particle Analyzer | |
| and Quantifier". Blood is placed into the PAQ inlet and then the | |
| PAQ is placed into the Reader (instrument). | |
| Bench tests were done to demonstrate correct function of: | |
| Quality Control Cassette (QCC) for testing of the PAQ | |
| electrical connection and Hemoglobin photometric function in | |
| the QCC mode. | |
| Liquid Quality Controls (LQCs) with White Blood Cell (WBC) | |
| PAQs with the Analyzer in the LQC mode | |
| Linearity materials with the Analyzer in the Linearity mode | |
| using WBC PAQs. | |
| Associated print-out of LQC, QCC, Linearity, and patient ID | |
| (from bar code scanner). | |
| Bench testing was done to show the Analyzer detected | |
| mismatches such as inserting the WBC PAQ in the QCC mode | |
| or the QC Cassette in the WBC mode. | |
| Bench performance testing was done to show that all WBC | |
| functionality was uncompromised by the modifications. | |
| Software verification and validation was done on all added | |
| functionality including code reviews and direct testing of software | |
| functionality (e.g. that correct information was shown on the | |
| Analyzer LCD depending on the mode selected). | |
| Conclusion: | Results of testing demonstrate that the modifications to the |
| Chempaq XBC Analyzer did not modify white blood cell or | |
| hemoglobin measurement functionality, that the added | |
| functionality performs as intended, and that potential risks (such | |
| as mismatching of PAQ/QCC and test mode) have been | |
| mitigated by software changes to detect such mismatches to | |
| deliver an error message and prevent reporting of results. | |
| We conclude that the modified Chempaq XBC Analyzer is as | |
| safe and effective as, and performs as well as, its unmodified | |
| version (predicate). |
Chempaq A/S Special 510(k)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 emblem featuring a symbol that resembles a caduceus or a staff with a snake winding around it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Chempaq A/S c/o Mr. Lone Hoffensets Quality Assurance Manager Hirsemarken 1 B 3520 Farum Denmark
APR 2 1 2009
Re: K090013
Trade/Device Name: Chempaq XBC Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: April 06, 2009 Received: April 09, 2009
Dear Mr. Hoffensets,
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); medical device reporting of 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
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Page 2 - Mr. Lone Hoffensets
quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing vour 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
m chan
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
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Indications for Use Statement 4
510(k) Number (if known): K090013
Device Name: Chempaq XBC Analyzer
Indications For Use:
The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the quantitative determination of the concentration of white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") in whole-blood samples (finger stick or venous sample).
The Chempag XBC Analyzer is indicated for use in: clinical laboratories, and for pointof-care hematology determinations in doctors' offices or by healthcare professionals in hospital settings to identify and classify one or more of the formed elements of blood.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR Over-The-Counter Use _
AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
emel A
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090013