(26 days)
No
The document describes a clinical chemistry and immunoassay analyzer system with automated sample handling and routing, but there is no mention of AI or ML technologies being used for analysis, interpretation, or system control beyond standard programming requirements.
No
This device is an in vitro diagnostic (IVD) system used for analyzing biological fluids to determine various chemistries and analytes; it does not provide therapy.
Yes
The device is explicitly described as a "clinical chemistry analyzer" and an "immunoassay analyzer" intended for "in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids". This indicates its use in analyzing samples to facilitate diagnosis.
No
The device description clearly outlines numerous hardware components including analyzers, aliquotters, reagent storage, sample delivery systems, detectors, electronics, and power supplies. While software is mentioned as part of the system, it is integrated with and controls significant physical hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states the system is "intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid" and "intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid". The phrase "in vitro determination" is a key indicator of an IVD.
- Device Description: The description details how the system analyzes biological fluids (serum, plasma, urine, CSF) using reagents and reaction constituents to perform clinical chemistry and immunoassay tests. This process of analyzing samples outside of the body to provide diagnostic information is the core function of an IVD.
- Use of Reagents, Calibrators, and Controls: The system operates in conjunction with "existing reagents, calibrators, and controls designed for use with Beckman Coulter's SYNCHRON and Access instrument families." These are essential components used in IVD testing to ensure accuracy and reliability.
- Predicate and Reference Devices: The listed predicate and reference devices (SYNCHRON LXi 725 System, UniCel DxC 600 System, SYNCHRON LX® Systems, Access® assays, etc.) are all known IVD instruments and assays. This further supports the classification of the UniCel DxC 600i System as an IVD.
N/A
Intended Use / Indications for Use
The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements.
The UniCel DxC 600 Synchron® Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent).
The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The analyzer performs enzyme immunoassays utilizing paramagnetic particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).
Product codes (comma separated list FDA assigned to the subject device)
CFR, JFP, CHL, CGZ, CEM, JGS, CDQ, DCK, JIY, LCD, DFT, JXM, LCP, JLW, JHI, JMG, CGN, JJE
Device Description
The UniCel DxC 600i System combines the UniCel DxC 600 analyzer and Access 2 immunoassay analyzer into a single instrument presentation. Samples are loaded from a single point of entry through the Closed Tube Aliquoter (CTA) connector unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or DxC 600 modules according to programming requirements. The DxC 600 and Access 2 systems then deliver samples to the appropriate reaction vessel along with reagents and reaction constituents. The DxC 600-based console functions as the main user interface for managing routine operations such as sample programming, results management, and QC functions.
The DxC 600i system provides analysis of up to 94 analytes per sample, operating in conjunction with the existing reagents, calibrators, and controls designed for use with Beckman Coulter's SYNCHRON and Access instrument families. The instrument features bar code identification of samples and reagents, Closed Tube Sampling (CTS), and obstruction detection and correction capability. DxC 600i system components include the DxC 600 analyzer and console, the CTA module, and the Access 2 module and console. The subsystem hardware components for the analytical units include reagent storage compartments, sample and reagent delivery systems, cap piercing assemblies, sample carousels and cranes, hydropneumatics, fluidics, photometric detectors, electronics, and power supplies.
The DxC 600i System incorporates the following upgrades to the LXi 725 System:
- General Chemistry Module: The UniCel DxC 600 System (previously reviewed/cleared under K042291) replaces the LX20 PRO System as the general chemistry module and main system console. The DxC 600 implements a dual-carousel refrigeration unit to increase reagent cartridge storage capacity and expand the onboard test menu. The DxC 600 offers robustness and feature enhancements over the LX20 PRO, and has a smaller instrument footprint to reduce the overall size of the "i" configuration.
- Hardware Modifications: The CTA unit upgrades address parts obsolescence and performance quality issues related to the barcode reader, syringe module and pump. The Access 2 module has updated electronic components to support the obstruction detection feature. There are also instrument cover changes to match the DxC 600 design.
- Software Modifications: The DxC 600i System utilizes DxC operating software version 1.4. Version 1.4 contains the information necessary to configure, order, and report results for Access 2 tests and an updated chemistry database. The Access 2 module operating software is updated to achieve alignment with stand-alone Access 2 operating software. The CTA module software is updated to implement robustness improvements and new features.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data from validation testing supports equivalency.
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.
K042291, K965240, K883181, K010597, K960485, K955644, K965108, K043556, K042459, K042281, K023480, K955434, K052082
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
FEB 2 7 2006
510(k) Summary UniCel® DxC 600i System
Submitted By: 1.0
Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea. CA 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
Date Submitted 2.0
January 31, 2006
3.0 Device Name(s):
- 3.1 Proprietary Names: UniCel® DxC 600i Synchron® Access® Clinical System
- 3.2 Classification Names: Discrete photometric chemistry analyzer for clinical use [862.2160]
4.0 Legally Marketed Device
The UniCel DxC 600i System claims substantial equivalence to the SYNCHRON LXi 725 System (Docket Number K023049) currently in commercial distribution.
5.0 Device Description
The UniCel DxC 600i System combines the UniCel DxC 600 analyzer and Access 2 immunoassay analyzer into a single instrument presentation. Samples are loaded from a single point of entry through the Closed Tube Aliquoter (CTA) connector unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or DxC 600 modules according to programming requirements. The DxC 600 and Access 2 systems then deliver samples to the appropriate reaction vessel along with reagents and reaction constituents. The DxC 600-based console functions as the main user interface for managing routine operations such as sample programming, results management, and QC functions.
The DxC 600i system provides analysis of up to 94 analytes per sample, operating in conjunction with the existing reagents, calibrators, and controls designed for use with Beckman Coulter's SYNCHRON and Access instrument families. The instrument features bar code identification of samples and reagents, Closed Tube Sampling (CTS), and obstruction detection and correction capability. DxC 600i system components include the DxC 600 analyzer and console, the CTA module, and the Access 2 module and console. The subsystem hardware components for the analytical units include reagent storage compartments, sample and reagent delivery systems, cap piercing assemblies, sample carousels and cranes, hydropneumatics, fluidics, photometric detectors, electronics, and power supplies.
The DxC 600i System incorporates the following upgrades to the LXi 725 System:
1
1. General Chemistry Module
The UniCel DxC 600 System (previously reviewed/cleared under K042291) replaces the LX20 PRO System as the general chemistry module and main system console. The DxC 600 implements a dual-carousel refrigeration unit to increase reagent cartridge storage capacity and expand the onboard test menu. The DxC 600 offers robustness and feature enhancements over the LX20 PRO, and has a smaller instrument footprint to reduce the overall size of the "i" configuration.
2. Hardware Modifications
The CTA unit upgrades address parts obsolescence and performance quality issues related to the barcode reader, syringe module and pump. The Access 2 module has updated electronic components to support the obstruction detection feature. There are also instrument cover changes to match the DxC 600 design.
Software Modifications 3.
The DxC 600i System utilizes DxC operating software version 1.4. Version 1.4 contains the information necessary to configure, order, and report results for Access 2 tests and an updated chemistry database. The Access 2 module operating software is updated to achieve alignment with stand-alone Access 2 operating software. The CTA module software is updated to implement robustness improvements and new features.
6.0 Intended Use
The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliquoter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or UniCel DxC 600 analyzer according to programming requirements.
The UniCel DxC 600 Synchron® Clinical System is a fully automated, computercontrolled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid, (sample type is chemistry dependent).
The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access The analyzer performs enzyme immunoassays utilizing paramagnetic instrument. particle solid phase and chemiluminescent detection. The Access 2 Analyzer is intended for the in vitro determination of a variety of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).
7.0 Comparison to the Predicate
The SYNCHRON LXi 725 system has been upgraded to a DxC 600i System through 1) replacement of the LX20 PRO module with a modified DxC 600 PRO analyzer, 2) modified CTA and Access 2 hardware elements and instrument covers, and, 3) software updates to the DxC 600, Access 2, and CTA modules. There is also a name change to UniCel DxC 600i System.
8.0 Summary of Performance Data
Performance data from validation testing supports equivalency.
2
Section 1: ADMINISTRATIVE INFORMATION
1.0 Submitted By:
Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000
Primary Contact: Mary Beth Tang, Staff Regulatory Affairs Specialist Telephone: (714) 961-3777 FAX: (714) 961-4123 E-mail: mtang@beckman.com
Secondary Contact: Annette Hellie, Staff Regulatory Affairs Specialist Telephone: (714) 993-8767 FAX: (714) 961-4123
Sponsor Address/FDA Registration Number 2.0
Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea. CA 92822-8000 Establishment Registration No. 2050012
Product Name/Classification Name and Number 3.0
Proprietary Names
UniCel® DxC 600i Synchron® Access® Clinical System
Classification Names
Discrete photometric chemistry analyzer for clinical use [862.2160]
4.0 Device Classification
FDA has classified clinical chemistry test systems of this type into Class I (reserved)
5.0 Section 514 Compliance
This Special 510(k): Device Modification submission is prepared pursuant to the FDA publication: The New 510(k) Paradigm: Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications -Issue Date: March 20, 1998.
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, or a symbol representing human connection and support.
Public Health Service
Food and Drug Administrat 2098 Gaither Road Rockville MD 20850
FEB 2 7 2006
Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000
K060256 Re: Rood200 Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Regulatory Class. Class II
Product Code: CFR, JFP, CHL, CGZ, CEM, JGS, CDQ, DCK, JIY, LCD, DFT, JXM, LCP, JLW, JHI, JMG, CGN, JJE Dated: January 31, 2006 Received: February 1, 2006
Dear Ms. Tang :
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we 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).
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Page 2 --
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and w you to ough finding of substantial equivalence of your device to a legally premated 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,
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K060256
Device Name: UniCel® DxC 600i Synchron® Access® Clinical System
Indications for Use:
The UniCel® DxC 600i System combines the UniCel® DxC 600 analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry allaiyeer into a Single Instrument procentations as a sample processing manager through a Closed Tube Aliquoter (STA) and The Children DxC 600 analyzer according to programming requirements.
The UniCel DxC 600 Synchron® Clinical System is a fully automated, computer-controlled clinical The Unicel DXC 000 Oynemon® Gillioan its of a variety of general chemistries, chemistly and other chemistries of clinical interest in biological fluids such as serum, therapeutio Grago, and others stillid, (sample type is chemistry dependent).
The Access 2 Immunoassay Analyzer is a microcomputer controlled, random access instrument. The Access 2 Intriumbassay Andryzer is a miss collizing paramagnetic particle solid phase and The analyzer performs Chizyno intinuneed for the in vitro determination of a Chemilian of analytes of clinical interest in biological fluids such as serum, plasma, urine, and cerebral spinal fluid, (sample type is chemistry dependent).
Prescription Use X (Part 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 807 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)
Carol Benson
AND/OR
Chico, CA
Carlos E.
K.060256
6
Indications for Use -- Submitted Analytes
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems Glucose (GLUCm) Reagent
Indications for Use:
GLUCm reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC GLOCM Teagent, when asca in conjanced min CAL 1 and 2, is intended for the ouantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
Glucose measurements are used in the diagnosis and treatment of carbohydrate rnetabolism Giocose nicabaromonio are are arellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems Carbon Dioxide (CO2) Assay
Indications for Use:
ISE Electrolyte Buffer reagent, ISE Electrolyte Reference reagent, CO2 Alkaline Buffer and CO2 Acid reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 3, are intended for quantitative determination of Carbon Dioxide concentration in human serum or plasma.
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems Calcium (CALC) Assay
Indications for Use:
ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2 are intended for quantitative determination of Calcium concentration in human serum, plasma or urine.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Carol Benson
7
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems Chloride (CL) Assay
Indications for Use:
ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in onjunction will a SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1 and 2, are intended for quantitative determination of Chloride concentration in hurnan serum, plasma, urine or cerebrospinal fluid (CSF).
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems Potassium (K) Assay
Indications for Use:
ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of Potassium concentration in human serum, plasma or urine.
Potassium measurements are used in the diagnosis and treatment of hypokalemia, renal failure, Addison's disease or other diseases involving electrolyte imbalance.
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems Sodium (NA) Assay
Indications for Use:
ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of Sodium concentration in human serum, plasma or urine.
Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Carol Bensen
060256
8
510(k) Number (if known): K965240, K042291, K060256
Device Name: SYNCHRON® Systems AQUA CAL 1, 2 and 3
Indications for Use:
The Beckman Coulter AQUA CAL 1, 2, and 3 are intended for use on SYNCHRON LX® and UniCel® DxC Systems for the calibration of Sodium, Potassium, Chloride, Urea, Glucose, Creatinine, Calcium, Carbon Dioxide, and Phosphorus.
510(k) Number (if known): K883181, K060256
Device Name: SYNCHRON® Systems Blood Urea Nitrogen (BUN) Reagent
Indications for Use:
BUN reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s) and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Urea Nitrogen concentration in human serum, plasma or urine.
Urea nitrogen or urea measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
510(k) Number (if known): K010597, K060256
Device Name: SYNCHRON® Systems High Sensitivity C-Reactive Protein (CRPH) Reagent
Indications for Use:
High Sensitivity CRPH reagent, when used in conjunction with SYNCHRON LX® PRO Systems, UniCel® DxC 600/800 Systems, and SYNCHRON® Systems CAL 5 Plus, is intended for the quantitative determination of C-Reactive Protein in human serum or plasma by rate turbidimetry.
Measurement of C-Reactive protein aids in the evaluation of stress, trauma, infection, inflammation, surgery, and associated diseases,
Carol Benson