(109 days)
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.
Automated differential cell counter
This document is a 510(k) summary for a modification to the Chempaq XBC Analyzer, a device already on the market. The summary focuses on functional and safety testing to demonstrate that the modifications did not compromise existing white blood cell or hemoglobin measurement functionality and that new functionalities perform as intended. Therefore, this submission does not contain a standalone study or a detailed report of clinical performance against acceptance criteria for the core diagnostic measures (WBC, GRN, LYM, MON, HGB) as it refers to an existing device and modifications.
Based on the provided text, the device is considered substantially equivalent to its predicate, meaning its performance is implied to be similar to the existing (predicate) device. However, specific acceptance criteria and detailed performance data for the diagnostic measurements themselves are not presented in this summary for the modified device.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of acceptance criteria or reported device performance for the diagnostic accuracy of WBC, GRN, LYM, MON, or HGB. The document focuses on the functional and safety testing of the modifications to the existing Chempaq XBC Analyzer.
The acceptance criteria mentioned are related to successful operation of:
- Quality Control Cassette (QCC) for PAQ electrical connection and Hemoglobin photometric function.
- Liquid Quality Controls (LQCs) with WBC PAQs.
- Linearity materials with the Analyzer in Linearity mode using WBC PAQs.
- Associated print-out of LQC, QCC, Linearity, and patient ID.
- Detection of mismatches (e.g., wrong PAQ in wrong mode).
- Uncompromised WBC functionality after modifications.
- Software verification and validation.
The "reported device performance" against these specific acceptance criteria is summarized qualitatively: "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."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes "bench tests" for functional and safety aspects. It does not specify the sample sizes (e.g., number of PAQs, QCCs, or samples tested) for these tests. Data provenance is not mentioned, but given the submitter is Chempaq A/S in Denmark, it's likely the testing was conducted internally by the manufacturer. The tests appear to be prospective, laboratory-based bench testing of the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This 510(k) summary describes functional and safety testing, not clinical performance for diagnostic accuracy. Therefore, there is no mention of experts establishing ground truth in the context of clinical interpretation or diagnosis. The ground truth for functional tests would be the expected correct behavior of the device (e.g., a printout should occur, an error message should display for incorrect input).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is functional and safety testing, not a clinical study requiring adjudication of diagnostic outcomes.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an automated differential cell counter, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data alongside AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document is a 510(k) for device modifications. It confirms that "Bench performance testing was done to show that all WBC functionality was uncompromised by the modifications." This implies that the device's automated functions (i.e., algorithm only) were tested. However, detailed results of this standalone performance are not provided, as the purpose of the submission is to demonstrate equivalence and safety of the modifications, not to re-establish the primary diagnostic performance. The original Chempaq XBC Analyzer's standalone performance would have been established in a previous 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the functional and safety testing described, the "ground truth" is the expected behavior and output of the device and its components, determined by engineering specifications and quality control standards (e.g., known values for liquid quality controls, expected printout content, correct error messages).
8. The sample size for the training set
Not applicable. This is a submission for modifications to an existing device, and the testing described is verification and validation of these modifications and their impact on existing functionality. It does not describe the development or training of new algorithms for diagnostic purposes.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for new algorithms in this submission.
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15090013
APR 2 1 2009
5 510(k) Summary
سمبر مار
| 510(k) Summary | |
|---|---|
| Submitter: | Chempaq A/SHirsemarken 1 B3520 FarumDenmark |
| Contact Person: | Lone HoffensetsQuality Assurance ManagerChempaq A/SHirsemarken 1 B3520 FarumDenmarkPhone 011-45 44390500Fax 011-45 44390539Email: 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 |
| DeviceDescription: | Automated differential cell counter |
| Intended Use: | The Chempaq XBC Analyzer is an in vitro diagnostic methodintended for the quantitative determination of the concentrationof white blood cells ("WBC"); granulocytes ("GRN"); lymphocytes("LYM"); monocytes ("MON"); and total hemoglobin ("HGB") inwhole-blood samples (finger stick or venous sample).The Chempaq XBC Analyzer is indicated for use in: clinicallaboratories, and for point-of-care hematology determinations indoctors' offices or by healthcare professionals in hospital settingsto identify and classify one or more of the formed elements ofblood. |
| 510(k) Summary | |
| Functional andSafety Testing: | Chempaq XBC Analyzer uses a single-use, reagent cassette(cartridge) called a "PAQ" which designates "Particle Analyzerand Quantifier". Blood is placed into the PAQ inlet and then thePAQ is placed into the Reader (instrument). |
| Bench tests were done to demonstrate correct function of: | |
| Quality Control Cassette (QCC) for testing of the PAQelectrical connection and Hemoglobin photometric function inthe 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 modeusing WBC PAQs. | |
| Associated print-out of LQC, QCC, Linearity, and patient ID(from bar code scanner). | |
| Bench testing was done to show the Analyzer detectedmismatches such as inserting the WBC PAQ in the QCC modeor the QC Cassette in the WBC mode. | |
| Bench performance testing was done to show that all WBCfunctionality was uncompromised by the modifications. | |
| Software verification and validation was done on all addedfunctionality including code reviews and direct testing of softwarefunctionality (e.g. that correct information was shown on theAnalyzer LCD depending on the mode selected). | |
| Conclusion: | Results of testing demonstrate that the modifications to theChempaq XBC Analyzer did not modify white blood cell orhemoglobin measurement functionality, that the addedfunctionality performs as intended, and that potential risks (suchas mismatching of PAQ/QCC and test mode) have beenmitigated by software changes to detect such mismatches todeliver an error message and prevent reporting of results. |
| We conclude that the modified Chempaq XBC Analyzer is assafe and effective as, and performs as well as, its unmodifiedversion (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
§ 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.”