(274 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 ("Hb") 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.
The Chempaq XBC Analyzer consists of a single use cartridge, called the PAQ (Particle Analyzer and Quantifier), and a stationary Reader with a docking station, called a Cradle. The PAQ is connected to the Cradle by a simple push fit. The PAQ includes all required reagents and will, when connected to the Cradle, perform all sample manipulations required for the analysis. The sample manipulation is facilitated by electrical and pneumatic connections between the PAQ and the Cradle. The user is not required to add any reagent to the Reader.
The test procedure is very simple, as the user is only required to apply blood to the PAQ and place it into the Cradle. The rest of the test is carried out automatically within 3 minutes. No manipulation of reagents or other materials by the user is required.
The Chempaq XBC Analyzer is an in vitro diagnostic method for the quantitative determination of the concentration of various blood components. The provided text, however, focuses primarily on the general performance and special studies conducted to validate the device, rather than specifying explicit acceptance criteria with numerical targets. It states that "In all instances, the Chempaq XBC Analyzer functioned as intended," which implies that the device met internal, pre-defined acceptance criteria, but these criteria are not explicitly detailed.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
As mentioned, specific numerical acceptance criteria are not explicitly stated in the provided text. The text confirms that the device "functioned as intended" in all tests, implying all criteria were met.
| Performance Parameter | Acceptance Criteria (Not Explicitly Stated, Implied as "Functioned as Intended") | Reported Device Performance |
|---|---|---|
| Precision and accuracy | Acceptable levels for diagnostic use (implied) | Functioned as intended |
| Venous vs. capillary samples | No significant difference in results between sample types (implied) | Functioned as intended |
| Linearity | Demonstrates linearity across the reportable range (implied) | Functioned as intended |
| Interferences | Minimal clinically significant interference (implied) | Functioned as intended |
| Pre-analytical errors | Robust to common pre-analytical errors (implied) | Functioned as intended |
| Stability studies | Maintains performance over defined storage and operating conditions (implied) | Functioned as intended |
| Batch variability (in-batch and between-batch) | Consistent performance within and between manufacturing batches (implied) | Functioned as intended |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text mentions "Testing was performed under two separate situations: 1) laboratory bench testing; and 2) point-of-use clinical testing, including point-of-care and physician office laboratory locations." However, the number of samples used in these tests is not provided.
- Data Provenance: The studies were conducted in "laboratory bench testing" and "point-of-use clinical testing, including point-of-care and physician office laboratory locations." The country of origin for the data is not specified, but the submitter, Chempaq A/S, is based in Copenhagen, Denmark, suggesting that some or all studies might have been conducted there or in clinics/labs associated with their operations. The studies appear to be prospective as they were conducted specifically for the validation of the Chempaq XBC Analyzer following approved test protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The text does not detail how ground truth was established for the test set, nor does it mention the involvement or qualifications of experts for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This is not applicable to the Chempaq XBC Analyzer. This device is an automated differential cell counter, meaning it performs the analysis itself, rather than assisting human readers in interpreting images or data. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done for the Chempaq XBC Analyzer. This is indicated by the "Performance Data" section which describes various tests directly evaluating the device's capabilities (precision, accuracy, linearity, stability, etc.) without human intervention in the analysis process. The device is described as operating "automatically within 3 minutes" after blood application.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the specific type of ground truth used. For diagnostic devices measuring blood cell concentrations, ground truth would typically be established using reference methods or established laboratory techniques known for their accuracy and precision. For example, manual differential counts by trained technologists, or comparison with results from highly accurate predicate devices or gold standard instruments. The mention of "NCCLS" (National Committee for Clinical Laboratory Standards) and "ICSH" (International Council for Standardization in Haematology) documents as references suggests that recognized industry standards for establishing ground truth and evaluation were followed.
8. The sample size for the training set:
This information is not provided in the document. For a device like this, the "training set" might refer to data used during the development and optimization of the underlying algorithms, but the document does not specify this.
9. How the ground truth for the training set was established:
This information is not provided in the document. Similar to the test set, it would likely involve highly accurate reference methods, but the specifics are not detailed.
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Koso758
DEC 2 2 2005
510(k) SUMMARY Chempaq A/S's Chempaq XBC Analyzer
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Chempaq A/S Symbion Science Park, Fruebjergvej 3, DK-2100 Copenhagen, Denmark
Phone: +45 3917 9960 Facsimile: +45 3917 9961
Frank Petersen, Manager of Quality and Regulatory Contact Person: Affairs
Date Prepared: 31 August 2005
Name of Device and Name/Address of Sponsor
Chempag XBC Analyzer Chempaq A/S Symbion Science Park, Fruebjergvej 3, DK-2100 Copenhagen, Denmark
Common or Usual Name
Automated Differential Cell Counter
Classification Name
Automated Differential Cell Counter
Predicate Device
Coulter® ACT™ diff Analyzer, manufactured by Beckman Coulter, Inc.
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
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("WBC"); granulocytes ("GRN"); lymphocytes ("LYM"); monocytes ("MON"); and ( WBO 7, Landino, ("Hb") 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.
Technological Characteristics
The Chempaq XBC Analyzer consists of a single use cartridge, called the PAQ (Particle Analyzer and Quantifier), and a stationary Reader with a docking station, called a Cradle. The PAQ is connected to the Cradle by a simple push fit. The PAQ includes all required reagents and will, when connected to the Cradle, perform all sample manipulations required for the analysis. The sample manipulation is facilitated by electrical and pneumatic connections between the PAQ and the Cradle. The user is not required to add any reagent to the Reader.
The test procedure is very simple, as the user is only required to apply blood to the PAQ and place it into the Cradle. The rest of the test is carried out automatically within 3 minutes. No manipulation of reagents or other materials by the user is required.
Performance Data
The performance validation of the Chempaq XBC Analyzer is divided into: 1) general performance studies; and 2) special studies as described below. Testing was performed under two separate situations: 1) laboratory bench testing; and 2) point-of-use clinical testing, including point-of-care and physician office laboratory locations. Test performance was evaluated for the following parameters:
- Precision and accuracy (general performance); .
- Venous vs. capillary samples (general performance); .
- Linearity (special study); .
- Interferences (special study); .
- Pre-analytical errors (special study); .
- Stability studies (general performance); .
- Batch variability (in-batch and between-batch). .
All performance testing was carried out following approved test protocols. Several National Committee for Clinical Laboratory Standards ("NCCLS") and International Council for Standardization in Haematology ("ICSH")
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documents were used as reference and are specifically identified in the 510(k) notice. In all instances, the Chempaq XBC Analyzer functioned as intended. Substantial Equivalence
The Chempaq XBC Analyzer is as safe and effective as the Coulter® ACTM diff Analyzer. The Chempaq XBC Analyzer has the same intended uses and 11 1 - diff Interf 2017 - The ological characteristics, and principles of operation as its smillar indicated to minor technological differences between the Chempaq XBC Prodoave and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Chempaq XBC Analyzer is as safe and r frective as Coulter® ACT™ diff Analyzer. Thus, the Chempaq XBC Analyzer is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Chempaq A/S c/o Jonathan S. Kahan Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109
DEC 2 2 2005
Re: K050758
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: October 28, 2005 Received: October 28, 2005
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) premailier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosare) to regars) to regally the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Medical Device American comments prior to May 20, 1978, the encordance with the provisions of the Federal Food, DNIg devices that have been rocussimou in asses approval of a premarket approval application (PMA). alle Cosment Act (Act) that to not require appears controls provisions of the Act. The I ou may, therefore, manot the Act include requirements for annual registration, listing of general controls provisions wastice, 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 If your device is classinou (600 a00 rols. Existing major regulations affecting your device can may be subject to subject to sublicions, Title 21, Parts 800 to 895. In addition, FDA may ov found in the Over in concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc activisou that i Drimination that your device complies with other requirements of the Act that I DA has made a develommations administered by other Federal agencies. You must of any I cuttar statures and registements, including, but not limited to: registration and listing (21 compry with and the read 801 and 809); and good manufacturing practice CIN Part 807), abouning (21 CF Raality systems (QS) regulation (21 CFR Part 820). This letter requirements as begin marketing your device as described in your Section 510(k) premarket win anow you to begin mating of your device of your device to a legally marketed noaticate 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, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the vitro Diagnostic Dover Doved by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may obtain of Scherar ars, 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/industry/support/index.html
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., MD, PA Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _____K050758
Device Name: Chempag XBC Analyzer
Indications for Use:
The Chempaq XBC Analyzer is an in vitro diagnostic method intended for the The Clempaq ADO Analy 2017 to to concentration of white blood cells ("WBC"); qualititative determination bocutes ("LYM"); monocytes ("MON"); and total grandiocytes ( CItiv ), 19mphooyees (finger stick or venous sample).
The Chempaq XBC Analyzer is indicated for use in: clinical laboratories, and for I he Chempaq ADO Thiaights is is is is a control offices or by healthcare point-of-care nematology decorminations in accessify one or more of the formed elements of blood.
Prescription Use __X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Office Diagnostic Device
Evaluation
510(k) K050758
\\DC - 20664/0001 - 2121432 v2
§ 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.”