(31 days)
The ABX MICROS CRP 200 is an open tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or or in CBC & Creactive protein (CRP) mode. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders. For the CRP mode, the MICROS CRP 200 uses dedicated HoribaABX reagents (ABX CRP REA), controls (ABX CRP TROL I & III) and calibrator (ABX CRP STD). The MICROS CRP 200 may be coupled, on option, with an information management (iM) system.
ABX MICROS CRP 200 is an automated hematology analyzer that was developed by Horiba ABX (Montpellier, France). It utilizes cytochemistry, focused flow imredance, light scattering, and turbidity to provide quantitative information on complete blood cell and differential counts, in addition to other hematology parameters and conventional CRP. CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lysed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
Acceptance Criteria and Device Performance for ABX MICROS CRP 200
The ABX MICROS CRP 200, its associated CRP reagent (ABX CRP REA), controls (ABX CRP TROL I-III), and calibrator (ABX CRP STD) have demonstrated substantial equivalence to the predicate device ABX MICROS CRP (cleared under K002646) through internal and external clinical studies and internal validation procedures. The device's fundamental scientific technology for hematology parameters remains consistent with the predicate. The primary modification addressed in this 510(k) was the provision of a higher linearity limit for the C-Reactive Protein (CRP) parameter using a new reagent and calibrator, and the addition of an optional information management system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study Type |
|---|---|---|---|
| Precision | Not explicitly stated but generally refers to reproducibility of results. | "Good precision in accordance with EP5-A (NCCLS guidelines) and is entirely acceptable for all available parameters." | Clinical Studies (Internal & External) |
| Linearity | WBC: 0 - 80 x 10^3/μL | "Entirely supported by the clinical data provided in this submission." | Clinical Studies |
| RBC: 0 - 7.5 x 10^9/μL | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| HGB: 0 - 23g/dl | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| HCT: 0 - 62.4% | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| PLT: 0 - 900 x 10^3/pL | "Entirely supported by the clinical data provided in this submission." | Clinical Studies | |
| Conventional CRP (Whole Blood): 0 - 200 mg/L | "Entirely supported by the clinical data provided in this submission." (Higher linearity limit for CRP was a key modification) | Clinical Studies | |
| Conventional CRP (Plasma): 0 - 150 mg/L | "Entirely supported by the clinical data provided in this submission." (Higher linearity limit for CRP was a key modification) | Clinical Studies | |
| Accuracy (Inter-procedural Correlation) | No significant bias expected compared to predicate devices. | "Showed no evidence of significant bias between the ABX MICROS CRP 200 and the predicate devices." | Clinical Studies |
| Sample Stability | Leukocyte counts and 3-part leukocyte differential: Acceptable for over 48 hours at room temperature and 4°C. | "Acceptable for over a 48 hour period from the time of blood collection at both room temperature and 4°C." | Clinical Studies |
| C-Reactive Protein determinations: Acceptable for over 72 hours at room temperature and 4°C. | "Assures there is sample stability over a 72 hour period at both room temperature and 4°C." | Clinical Studies | |
| Carryover | < 2.0% for WBC, RBC, HGB, PLT & CRP parameters. | No effect of contamination (carryover < 2.0%) was dissimulated by clinical data. | Clinical Studies |
| Safety (Electrical/EMC) | Compliance with IEC 61010-1 standard. | "The device meets with the IEC 61010-1 standard." | Non-clinical Tests |
| Compliance with EN 61326 standard. | "As well as the EN 61326 standard for Electromagnetic Compatibility." | Non-clinical Tests |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set in the clinical studies. It broadly refers to "internal & external clinical studies" and "clinical data provided in this submission."
The data provenance is not specified in terms of country of origin. The studies are referred to as "internal & external clinical studies" and "internal validation procedures," suggesting a mix of internal development and potentially external verification. The submission originated from Horiba ABX Montpellier, France, implying the internal studies were conducted there. Whether external studies involved other countries or sites is not detailed. The studies were likely retrospective and prospective as they cover initial validation and performance for the modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies focus on instrument performance (precision, linearity, accuracy, stability, carryover) rather than an expert-adjudicated diagnostic task.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Given the nature of the device (automated hematology analyzer and CRP measurement), the evaluation primarily involves comparing measurements obtained by the device against reference methods or predicate devices, and internal quality control standards, rather than expert consensus on diagnostic interpretations.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. The effectiveness studies focused on the analytical performance of the device itself.
6. Standalone Performance Study
Yes, a standalone study was done. The entire submission details the performance of the ABX MICROS CRP 200 device in a standalone capacity (algorithm only, without human-in-the-loop performance, in the context of an automated analyzer) for generating quantitative measurements of hematology parameters and CRP. The "Discussion of Performance Data" focuses entirely on the device's analytical capabilities.
7. Type of Ground Truth Used
The ground truth for the performance studies was implicitly established through:
- Reference Methods/Predicate Devices: For accuracy, the new device's results were compared against "predicate devices," implying the predicate served as the reference standard.
- Established Analytical Standards: Precision and linearity were assessed against NCCLS guidelines (EP5-A), which set the standard for acceptable performance.
- Control Materials: Precision and stability studies would use assayed control materials with known target values.
- Calibrators: CRP measurements rely on calibration against known standards.
Therefore, the ground truth is based on reference methods, established analytical standards, and control/calibrator materials rather than expert consensus, pathology, or outcomes data in the traditional sense of a diagnostic interpretation task.
8. Sample Size for the Training Set
This information is not provided in the document. The document refers to "internal & external clinical studies" without differentiating between training and testing data sets in detail. For an in vitro diagnostic device of this type, the "training" (development and optimization) often involves iterative testing and refinement with a variety of samples rather than a formally defined, distinct "training set" like in machine learning. However, the exact sample numbers used for developing the original algorithms or optimizing the CRP reagent/calibrator are not disclosed.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the specific methodology and ground truth establishment for a "training set" are not explicitly described. For an automated analyzer, the development and "training" process typically involves:
- Internal R&D Testing: Using a large number of patient samples, spiked samples, and control materials to optimize algorithms, reagent formulations, optical systems, and fluidics.
- Comparative Analysis: Ensuring the device's measurements align with established reference methods or existing, validated analyzers (predicate devices).
- Verification and Validation Studies: Conducting extensive internal testing to challenge the system across its entire analytical range and various conditions.
The ground truth during this developmental phase would be established by reference laboratory methods, validated predicate devices, and gravimetrically/volumetrically prepared standards, similar to the ground truth used for the final performance validation.
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DEC 2 9 2005
Premarket Notification [510(k)] Summary
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 : 10533308
- Company: Horiba ABX 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: 22nd November 2005
Instrument :
CRP
| Trade/Proprietary Name: | ABX MICROS CRP 200 |
|---|---|
| Common or Usual Name: | Automated cell counter andAutomated differential cell counter |
| Device Class | Class II : Special Controls Guidance Document |
| Classification Name: | Automated cell counter (§864.5200) andAutomated differential cell counter (§864.5220) |
| Product Code: | GKZ : for the hematology analyzer |
| CRP Reagent | |
| Trade/Proprietary Name: | ABX CRP REA |
| Common or Usual Name: | Conventional CRP Reagent |
| Device Class | Class II : Special Controls Guidance Document |
| Classification Name: | C-reactive protein immunological test system(§866.5270) |
| Product Code: | DCK :C-reactive protein, antigen, antiserum, and control |
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CRP Control
| Trade/Proprietary Name: | ABX CRP TROL I-III |
|---|---|
| Common or Usual Name: | CRP Control |
| Device Class | Class I : exempt general conditions |
| Classification Name: | Quality Control Material (assayed & unassayed)(§862.1660) |
| Product Code: | JJXSingle (specified) analyte controls (assayed andunassayed) |
| CRP Calibrator | |
| Trade/Proprietary Name: | ABX CRP STD |
| Common or Usual Name: | CRP Calibrator |
| Device Class | Class II |
ice Class Class II Classification Name: : Quality Control Material (assayed & unassayed) (§862.1150) Product Code: JIS : Calibrator, primary
Optional device name :
| Trade/Proprietary Name: | iM (Information Management) |
|---|---|
| Common or Usual Name: | Laboratory Information System |
| Device Class | Class I : exempt |
| Classification Name: | Calculator/data processing module for clinical use($862.2100) |
| Product Code: | JQP |
Substantial Equivalence:
The ABX MICROS CRP 200 can be considered substantially equivalent to the predicate device ABX MICROS CRP cleared to market under K002646.
The fundamental scientific technology for the analyzer itself has not changed. All parameters for complete blood count, differential leucocyte count, the reagents and controls, measuring principles, and the principles of operation are the same as previously cleared by the FDA.
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The dedicated CRP reagents used on the ABX MICROS CRP 200 can be considered substantially equivalent to those previously used on the ABX MICROS CRP.
In addition, an optional add-on, to provide an Information Management System (iM) through which the ABX Micros CRP 200 ensures file management.
The overall effects on the Safety and Effectiveness of the Micros CRP 200 and the associated CRP reagents, controls and calibrators have been evaluated in internal & external clinical studies and internal validation procedures.
There is no known risk to the device Safety and Effectiveness.
Description:
ABX MICROS CRP 200 is an automated hematology analyzer that was developed by Horiba ABX (Montpellier, France). It utilizes cytochemistry, focused flow imredance, light scattering, and turbidity to provide quantitative information on complete blood cell and differential counts, in addition to other hematology parameters and conventional CRP.
CRP levels are measured in patients by reacting anti-CRP antibody coated latex particles with lysed blood, and determining the rate of the turbidimetric reaction in the near infrared spectrum.
Intended Use:
The ABX MICROS CRP 200 is an open tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or or in CBC & Creactive protein (CRP) mode.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
For the CRP mode, the MICROS CRP 200 uses dedicated HoribaABX reagents (ABX CRP REA), controls (ABX CRP TROL I & III) and calibrator (ABX CRP STD).
The MICROS CRP 200 may be coupled, on option, with an information management (iM) system.
Discussion of Performance Data:
The studies and data analysis were carried out in accordance with appropriate indications given by the FDA guidelines.
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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 evailable parameters.
The linearity claim for the parameters WBC (0 - 80 x 103/μL), RBC (0 - 7.5 x 109/μL), HGB (0 - 23g/dl), HCT (0 - 62.4%), PLT (0 - 900 x 103/pL), conventional CRP for whole blood (0 - 200 mg/L), and plasma (0 -- 150 mg/L) are entirely supported by the clinical data provided in this submission.
Accuracy (Inter-procedural Correlation) showed no evidence of significant bias between the ABX MICROS CRP 200 and the predicate devices.
The sample stability for leukocyte counts and the three part leukocyte differential is acceptable for over a 48 hour period from the time of blood collection at both room temperature and 4°C. For C-Reactive Protein determinations data assures there is sample stability over a 72 hour period at both room temperature and 4°C.
No effect of contamination of the instrument was dissimulated by the clinical data of this study, supporting a carryover claim of < 2.0% for WBC, RBC, HGB, PLT & CRP parameters.
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 61010-1 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.
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SPECIAL 510(k): Device Modification ODE Review Memorandum
To: THE FILE RE: DOCUMENT NUMBER K053308
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):
-
- The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
-
- Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
-
- A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
This change was for: 1. Providing a higher linearity limit for the CRP (C-Reactive Protein) parameter through the use of a new reagent and calibrator, 2. Adding an optional information management system.
-
- Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance data such as precision, linearity, accuracy, sample stability, and carry-over.
-
- A Design Control Activities Summary which includes:
- a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
- b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
- c) A declaration of conformity with design controls. The declaration of conformity should include:
- A statement signed by the individual responsible, that, as required by the risk analysis, all i) vertification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
- ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).
The labeling for this modified subject device has been reviewed to verify that the indicationlintended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommond the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
12-27-05 (Reviewer's Signature) (Date) Comments
revised:3/27/98
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Tim Lawton Regulatory Affairs Manager Horiba ABX Parc Euromèdecine Rue du Caducèe-BP 7290 34184 Montpellier cedex 4 France
DEC 2 9 2005
Re: K053308
Trade/Device Name: ABX MICROS CRP 200 (option: iM) ABX CRP REA ABX CRP TOL I & III ABX CRP STD
Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ, DCK, JJX, JIS, JQP Dated: November 22, 2005 Received: November 29, 2005
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
Image /page/5/Picture/12 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the wings of a bird. The caduceus is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
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Page 2 - Mr. Tim Lawton
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 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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours.
Robert Becker
Robert L. Becker, Jr., MD, Ph.D 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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510(k) Number (if known): K053308
Device Name: ABX MICROS CRP 200 (option : iM)
Indications For Use:
The ABX MICROS CRP 200 is an open tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or in CBC & Creactive protein (CRP) mode.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
The MICROS CRP 200 may be coupled, on option, with a information management (iM) system.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert Becker
Division Sign-Off
Page 1 of 1____1_
Office of In Vitro Diagnostic Device Evaluation and Safe 510(k)
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510(k) Number (if known): K053308
Device Name: ABX CRP STD
Indications For Use:
The ABX CRP STD is intended to be used for the calibration of the ABX CRP REA reagent on the ABX MICROS CRP 200 hematology analyzer for quantitative determination of C-reactive protein in human whole blood or plasma serum.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert R. Beckerleaf
Division Sign-Off
Page 1 of 1_____________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) Number (if known): K053308
Device Name: ABX CRP TROL I & III
Indications For Use:
The ABX CRP TROL I & III are intended to be used for the control of the ABX CRP REA reagent on the ABX MICROS CRP 200 hematology analyzer for quantitative determination of C-reactive protein in human whole blood or plasma serum.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert L. Reed
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostig Devico Evaluation and Safer
510(k) KC53308
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510(k) Number (if known): K053308
Device Name: ABX CRP REA
Indications For Use:
The ABX CRP REA is a quantitative assay for use with the ABX MICROS CRP 200 hematology analyzer for the determination of C-reactive protein in human whole blood or plasma serum.
Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Robert H. Beckef
Page 1 of _1
Office of In Vitro Dia Evaluation and Sa
510(k) K053308
§ 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.”