(427 days)
The Diatron Abacus 3CP System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%, GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in K3EDTA anti-coagulated venous whole blood samples. The Diatron Abacus 3CP is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
The 'Abacus 3CP' is a fully automated, bench top hematology cell counter with a cap piercing function. It uses the impedance-method for counting cells passing through a small aperture, and measures the hemoglobin content of red blood cells using a photometric method. The analyzer features a color graphical LCD display module and a foil keypad of 29 keys including 6 software buttons, 6 function keys and a START button. The instrument allows printing reports to an external printer (USB port), or can have an optional built-in printer module. Its internal memory is capable of storing 1000 records with full histograms, and individual patient data. The QC measurements are stored in a separate database. The software operating the instrument can be updated by using a USB flash memory device. The instrument can be connected to a host computer for uploading records in its memory through a USB SLAVE port (USB B) or serial link (RS232). Archiving records to an USB flash memory device is also possible.
The provided text describes the 510(k) summary for the Diatron Abacus 3CP Automated Hematology Analyzer (K111534). It compares its performance to a predicate device, the Abbott CELL-DYN® 1800 (K030513), to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it relies on demonstrating equivalence to the predicate device. The performance section states:
"All performance and accuracy data and data analysis in this submission support and substantiate equivalence to the selected predicate device (Abbott CELL-DYN® 1800 (K030513))."
This implies that the acceptance criteria are met if the device's performance is comparable to that of the legally marketed predicate device. The detailed performance data, which would show the "reported device performance" and how it compares to the predicate, is not included in this summary. It would likely be in the full submission. The key performance metrics mentioned are the ability to accurately enumerate the specified hematology parameters.
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 does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It generally states that "a representative sample of the device underwent software and system verification and validation testing."
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)
The document does not provide any information regarding the number or qualifications of experts used to establish the ground truth for the test set. For hematology analyzers, the ground truth is typically established through reference methods or manual microscopy performed by trained laboratory professionals (medical technologists, hematologists).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an automated hematology analyzer, directly measuring parameters, and does not involve human readers interpreting images with or without AI assistance. It's a standalone diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was implicitly done. The "Abacus 3CP, Automated Hematology Analyzer" is designed for "in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters". This indicates that the device operates automatically without human intervention in the primary measurement and calculation of parameters. Its performance is assessed as a standalone system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated, for hematology analyzers, the ground truth is typically established by:
- Reference methods: Highly accurate and precise laboratory methods (e.g., manual cell counts, flow cytometry for cell differentials) are used as the gold standard to which the automated analyzer's results are compared.
- Manual microscopy (expert review): For certain parameters, especially cell differentials or identification of abnormal cells, expert microscopic review by trained medical technologists or hematologists serves as the ground truth.
8. The sample size for the training set
The document does not mention a "training set" or its sample size. This is typical for a device like an automated hematology analyzer, where the algorithms (methodologies for calculating parameters like impedance counting and photometric measurement) are based on established scientific principles rather than being "trained" on a dataset in the modern machine learning sense. The device's performance is validated through verification and validation testing, not through training data.
9. How the ground truth for the training set was established
As there's no mention of a "training set" in the context of machine learning, there's no information on how its ground truth would have been established. The core methodologies of the device (impedance, photometry, calculations) are deterministic and based on physical principles, not a learned model.
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2 2012 AUG
510(k) Summary
| 510(k) Summary | |
|---|---|
| Submitter: | Diatron US Inc.14026 W. 107th StreetLenexa, Kansas 66215-2005 |
| ContactPerson: | Michael Switzer, Director, Quality AssuranceP: 954-790-9550F: 954-827-2644E: mike.switzer@diatron.com |
| DatePrepared: | April 27, 2012 |
| Trade Name: | Abacus 3CP, Automated Hematology Analyzer |
| Classification: | Class IIAutomated Differential Cell Counter21 CFR §864.5220 |
| ProductCode: | GKZ |
| PredicateDevice(s): | The subject device is equivalent to the following device:Abbott CELL-DYN® 1800 (K030513) |
| DeviceDescription: | The 'Abacus 3CP' is a fully automated, bench top hematology cell counter with a cappiercing function. It uses the impedance-method for counting cells passing through asmall aperture, and measures the hemoglobin content of red blood cells using aphotometric method. The analyzer features a color graphical LCD display module anda foil keypad of 29 keys including 6 software buttons, 6 function keys and a STARTbutton. The instrument allows printing reports to an external printer (USB port), or canhave an optional built-in printer module. Its internal memory is capable of storing 1000records with full histograms, and individual patient data. The QC measurements arestored in a separate database. The software operating the instrument can be updatedby using a USB flash memory device. The instrument can be connected to a hostcomputer for uploading records in its memory through a USB SLAVE port (USB B) orserial link (RS232). Archiving records to an USB flash memory device is also possible. |
| Indications forUse: | The Diatron Abacus 3CP System is a quantitative multi-parameter automatedhematology analyzer designed for in-vitro-diagnostic use in clinical laboratories forenumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%,GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in K3EDTA anti-coagulated venous whole blood samples. The Diatron Abacus 3CP is indicated for useto identify patients with hematologic parameters within and outside of establishedreference ranges. |
| Functionaland SafetyTesting: | To verify that device design met it's functional and performance requirements, arepresentative sample of the device underwent software and system verification andvalidation testing, in accordance with Class II Special Controls Guidance Document:Premarket Notifications for Automated Differential Cell Counters for Immature orAbnormal Blood cells. A risk and hazard analysis was performed per ISO 14971. |
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| Substantial | Similarities | |||
|---|---|---|---|---|
| Equivalence: | Item | Diatron Abacus 3CP | Abbott CELL-DYN 1800 | |
| Indication for Use | The Diatron Abacus 3CP System is aquantitative multi-parameter automatedhematology analyzer designed for in-vitro-diagnostic use in clinical laboratories forenumeration of the following parameters:WBC, LYM%, LYM#, MID%, MID#,GRA%, GRA#, RBC, HGB, HCT, MCV,MCH, MCHC, RDW, PLT, MPV inK3EDTA anti-coagulated venous wholeblood samples. The Diatron Abacus 3CPis indicated for use to identify patients withhematologic parameters within andoutside of established reference ranges. | The CELL-DYN 1800 System is anautomated, multiparameterhematology analyzer designed toreport sixteen parameters relatingto the cells of EDTA-anticoagulatedblood. | ||
| Number ofParameters | 16 | Same | ||
| Methodology | WBC = ImpedanceLYM = CalculatedLYM% = DerivedMID = CalculatedMID% = DerivedGRA = CalculatedGRA% = DerivedRBC = ImpedanceHGB = PhotometricHCT = CalculatedMCV = DerivedMCH = CalculatedMCHC = CalculatedRDW = DerivedPLT = ImpedanceMPV = Derived | Same | ||
| Sample Type | K3 EDTA anticoagulated venous wholeblood | Same | ||
| Sample Container | Open and Closed | Same | ||
| Sampling System | Manual | Same | ||
| Samples per hour | 60 | Same | ||
| Aperture Diameter | WBC 100 µm; RBC/PLT 80 µm | Same | ||
| Differences | ||||
| ItemSample Volume | Diatron Abacus 3CPOpen Vial Mode – 100 µLClosed Vial Mode – 100 µL | Abbott CELL-DYN 1800Open Vial Mode – 30 µLClosed Vial Mode - 450 µL | ||
| Performance: | All required software and system verification and validation procedures have been executedand analyzed per FDA recommended standards and the Class II Special ControlsGuidance Document: Premarket Notifications for Automated Differential Cell Counters forImmature or Abnormal Blood Cells. All risk and hazard analysis have been performed anddocumented per ISO 14971 guidelines. All performance and accuracy data and dataanalysis in this submission support and substantiate equivalence to the selected predicatedevice (Abbott CELL-DYN® 1800 (K030513)). | |||
| Conclusion: | Diatron considers the Abacus 3CP to be equivalent to the predicate device listedabove. This conclusion is based upon the devices' similarities in principles ofoperation, technology, and indications for use. | |||
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the edge. In the center is a stylized emblem that resembles a bird or abstract human figures, symbolizing health and human services.
10903 New Hampshire Avenue Silver Spring, MD 20993
AUG 0 2 2012
Diatron US Inc. c/o Mr. Michael Switzer Director, Quality Assurance 14026 W. 107th Street Lenexa. KS 66215-2005
Re: K111534
Trade/Device Name: Abacus 3CP Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: July 30, 2012 Received: July 31, 2012
Dear Mr. Switzer:
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 class II (Special Controls), 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 (reporting of
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Page 2 - Mr. Michael Switzer
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Riena Philip
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 Form
510(k) Number (if known): K111534
Device Name: Abacus 3 CP
Indications for Use:
The Diatron Abacus 3CP System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%, GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in KgEDTA anticoagulated venous whole blood samples. The Diatron Abacus 3CP is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurregce of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111534
§ 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.”