(165 days)
Not Found
No
The summary describes a standard automated hematology analyzer using established methodologies (impedance, RF, flow cytometry, spectrophotometry, supravital staining) for quantitative analysis. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The purpose is described as separating normal patients from those needing further studies based on system-generated parameters, which is typical for automated analyzers and does not inherently require AI/ML.
No
The device is an in vitro diagnostic hematology analyzer used for screening and providing quantitative information on blood and body fluid parameters, rather than directly treating or preventing a disease.
Yes
The phrases "in vitro diagnostic use," "screening patient populations," "helps diagnose the patient's condition," and "quantitative, automated hematology analyzer" indicate that the device is used for diagnostic purposes.
No
The device description explicitly states the system is comprised of an "analyzer" and "analytical reagents," indicating significant hardware components beyond just software. The methodologies mentioned (impedance, RF, flow cytometric light scatter, spectrophotometry, supravital staining) also require specialized hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use/Indications for Use: The very first sentence clearly states: "The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories."
- Explicit Statement in Device Description: The first sentence of the Device Description also states: "The UniCel® DxH 800 Coulter® Cellular Analysis System (DxH 800 System) is intended for In Vitro Diagnostic Use in clinical laboratories."
- Nature of the Tests Performed: The device performs tests on whole blood and body fluids (cerebrospinal, serous, and synovial) to measure hematological parameters. These are all samples taken from the body and analyzed outside the body, which is the definition of in vitro.
- Purpose of the Device: The purpose is to "separate the normal patient... from the patient who needs additional studies," which is a diagnostic screening function.
The document repeatedly and explicitly identifies the device as being for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides:
- a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
- a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The UniCel® DxH 800 Coulter® Cellular Analysis System (DxH 800 System) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and TNCs in body fluids.
The purpose of the DxH 800 System is intended to separate the normal patient. with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hematological parameters through the use of impedance, RF, flow cytometric light scatter, spectrophotometry, and supravital staining methodologies. Additional reagents provide system cleaning and quality control and calibration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy, repeatability (precision), measuring (linearity) range and carryover studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
KOH30
DEC 1 9 2008
510(k) Summary UniCel® DxH 800 Coulter® Cellular Analysis System
1.0 Submitted By:
Lourdes Coba Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4079 FAX: (305) 380-4344
2.0 Date Submitted:
July 3, 2008
3.0 Device Name(s):
3.1 Proprietary Names
UniCel® DxH 800 Coulter® Cellular Analysis System
3.2 Classification Name
Automated differential cell counter (21 CFR § 864.5220)
4.0 Predicate Devices:
| Candidate | Predicates | Manufacturer | Docket
Number |
|---------------------------------------------------------|----------------------------------------|-----------------------|------------------|
| UniCel® DxH 800
Coulter® Cellular
Analysis System | COULTER® LH 750
Hematology Analyzer | Beckman Coulter, Inc. | K011342 |
| | COULTER® LH 780
Hematology Analyzer | Beckman Coulter, Inc. | K061616 |
1
5.0 Description:
The UniCel® DxH 800 Coulter® Cellular Analysis System (DxH 800 System) is intended for In Vitro Diagnostic Use in clinical laboratories. The DxH 800 System provides automated complete blood count, leukocyte differential, NRBC enumeration and reticulocyte analysis as well as an automated method for enumeration of RBCs and TNCs in body fluids.
The purpose of the DxH 800 System is intended to separate the normal patient. with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patient's condition.
The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hematological parameters through the use of impedance, RF, flow cytometric light scatter, spectrophotometry, and supravital staining methodologies. Additional reagents provide system cleaning and quality control and calibration.
6.0 Intended Use:
The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides:
- a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
- a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
UniCel® DxH 800 Analyzer Abbreviated 510(k) Notification
2
| Characteristic | COULTER® LH 750 (Predicate) | COULTER® LH 780 (Predicate) | UniCel® DxH 800 |
|---|---|---|---|
| Intended Use | The COULTER LH 750 | ||
| Hematology Analyzer is a | |||
| quantitative, automated | |||
| hematology analyzer and | |||
| leukocyte differential counter | |||
| For In Vitro Diagnostic Use in | |||
| clinical laboratories. The | |||
| COULTER LH 750 Hematology | |||
| Analyzer provides automated | |||
| Reticulocyte analysis and | |||
| enumeration of nucleated red | |||
| blood cells (NRBCs) as well as | |||
| an automated method for | |||
| enumeration of RBCs and | |||
| WBCs in body fluids. | The COULTER LH 780 Hematology | ||
| Analyzer is a quantitative, automated | |||
| hematology analyzer and leukocyte | |||
| differential counter For In Vitro | |||
| Diagnostic Use in clinical | |||
| laboratories. The COULTER LH 780 | |||
| Hematology Analyzer provides | |||
| automated Reticulocyte analysis and | |||
| enumeration of nucleated red blood | |||
| cells (NRBCs) as well as an | |||
| automated method for enumeration | |||
| of RBCs and WBCs in body fluids. | The UniCel® DxH 800 Analyzer is a | ||
| quantitative, automated hematology | |||
| analyzer for in vitro diagnostic use in | |||
| screening patient populations found in | |||
| clinical laboratories. The UniCel® DxH | |||
| 800 Analyzer provides: | |||
| ■ a Complete Blood Count (CBC), | |||
| Leukocyte 5 Part Differential | |||
| (Diff), Reticulocyte (Retic) and | |||
| Nucleated Red Blood Cell (NRBC) | |||
| on whole blood | |||
| ■ a Total Nucleated Count (TNC) and | |||
| Red Cell Count (RBC) on Body | |||
| Fluids (cerebrospinal, serous and | |||
| synovial) (BF) | |||
| Parameters | |||
| IVD | WBC, RBC, Hgb, Hct, MCV, | ||
| MCH, MCHC, RDW, Plt, MPV, | |||
| LY%, MO%, NE%, EO%, | |||
| BA%, LY#, MO#, NE#, EO#, | |||
| BA#, NRBC%, NRBC#, RET%, | |||
| RET#, IRF, & MRV. | WBC, RBC, Hgb, Hct, MCV, MCH, | ||
| MCHC, RDW, RDW-SD, Plt, MPV, | |||
| LY%, MO%, NE%, EO%, BA%, | |||
| LY#, MO#, NE#, EO#, BA#, | |||
| NRBC%, NRBC#, RET%, RET#, | |||
| IRF, & MRV. | Same as LH 750 / 780 except WBC | ||
| reported as Total Nucleated Cell Count | |||
| (TNC) in body fluids | |||
| Characteristic | COULTER® LH 750 (Predicate) | COULTER® LH 780 (Predicate) | UniCel® DxH 800 |
| Quality | |||
| Control | |||
| Techniques | Daily Instruments Check, | ||
| Commercial Controls, Delta | |||
| Checks, Patient Controls, XB | |||
| Analysis, & IQAP. | Daily Instruments Check, | ||
| Commercial Controls, Delta Checks, | |||
| Patient Controls, XB Analysis, & | |||
| IQAP, Extended QC & XM Analysis | Same as LH 750 / 780 | ||
| Quality | |||
| Controls & | |||
| Calibrator | COULTER® 5C® Cell Control |
COULTER® Latron™ Primer
and Latron Control
COULTER® RETIC-C™ Cell
Control
COULTER® LIN-C® Linearity
Control
COULTER® S-CAL®
calibrator kit | COULTER® 5C® Cell Control
COULTER® Latron™ Primer and
Latron Control
COULTER® RETIC-C™ Cell
Control
COULTER® LIN-C® Linearity
Control
COULTER® S-CAL® Calibrator
Kit | COULTER® 6C Cell Control (pending
clearance K081822)
COULTER® Latron™ CP-X Control
(same product as Latron Control)
COULTER® RETIC-X Cell Control
(same product as Retic-C)
COULTER® LIN-X control (pending
clearance K081641)
COULTER® S-CAL® Calibrator kit
COULTER® Body Fluids Control
(pending 510k submission) |
| | COULTER® LH Series Diluent
COULTER® Isoton 4 Diluent
COULTER LH Series Pak
COULTER® LH Series RETIC
Pak | COULTER® LH Series Diluent
COULTER® Isoton 4 Diluent
COULTER® LH Series Pak
COULTER® LH Series RETIC Pak | COULTER® DH Diluent
COULTER® DH Diff Pack
COULTER® DH Retic Pack
COULTER® DH Cell Lyse |
| | Analysis
Reagents | COULTER® Lyse S® III lytic
agent
COULTER® Lyse S® 4 lytic
agent | COULTER® Lyse S® III lytic agent
COULTER® Lyse S® 4 lytic agent |
Comparison to Predicate(s) 7.0
UniCel® DxH 800 Analyzer
Abbreviated 510(k) Notification
Page 20
3
UniCel® DxH 800 Analyzer
Abbreviated 510(k) Notification
Page 21
4
| UniCel® DxH 800 | COULTER® DH Cleaner |
|---|---|
| COULTER® LH 780 (Predicate | |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | COULTER® LH Series Cleaner |
| TH 750 | |
| Predicate) | |
| COULTER® |
| CLENZ
COULTER® |
| Characteristic
A STATE A STATE LEAST PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTIC PARTY | Cleaning
Agent |
.
UniCel® DxH 800 Analyzer
Abbreviated 510(k) Notification
5
8.0 Summary of Performance Data:
Accuracy, repeatability (precision), measuring (linearity) range and carryover studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
6
Image /page/6/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2008
Beckman Coulter, Inc. C/o Lourdes Coba 11800 S.W. 147th Avenue Miami, Florida 33196
Re: K081930
Trade/Device Name: Unicel® DxH 800® Coulter Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: December 16, 2008 Received: December 17, 2008
Dear Ms. Coba:
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 notification. The FDA finding of substantial equivalence of your device to a legally marketed
7
Page 2 -- Ms. Coba
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" (21CFR 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. 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,
Josephine Bautista
ing Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
15081930 510(k) Number (if known):
Device Name: UniCel® DxH 800 Coulter® Cellular Analysis System
Indications For Use:
The UniCel® DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel® DxH 800 Analyzer provides:
- 트 a Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood
- I a Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF)
Prescription Use × (21 CFR Part 801 Subpart D) And/Or
Over The Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Josephine Bautista
Division Office/of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081930
Page 1 of 1
UniCel® DxH 800 Analyzer Abbreviated 510(k) Notification Page 16