(22 days)
No
The description focuses on automated sample handling, routing, and standard analytical processes, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
The device is described as a clinical chemistry and immunoassay analyzer, which performs in vitro determination of analytes in biological fluids. It is an IVD (In Vitro Diagnostic) device, not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states that the SYNCHRON LX®i 725 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". The determination of these analytes in biological fluids for clinical interest is a diagnostic function.
No
The device description explicitly details numerous hardware components including analyzers, aliquotters, probes, detectors, and mechanical systems, indicating it is a hardware-based system with integrated software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document 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, cerebrospinal fluid) using chemical and immunoassay methods. This aligns with the function of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Biological Fluids: The analysis is performed on biological fluids, which are typical sample types for IVD testing.
Therefore, based on the provided text, the SYNCHRON LX®i 725 System is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON LX®i 725 System combines the SYNCHRON LX®20 PRO analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliguotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements.
The SYNCHRON LX20 PRO 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 chemisiries 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)
JGS; CHH, CDZ, CEO, DIH, JHB, JIF, JIY, JMO, CDD, CDP, CDQ, CEC, CEE, CEK, CEM, CFJ, CFR, CGA, CGR, CGS, CGX, CGZ, CIN, CJE, CJW, CZP, DCF, DCK, DDC, DDG, DDG, DDR, DFT, DGC, DHR, DIO. DIS, DJG, DJR, DKJ, DKZ, DLZ, DMT, GTQ, JFJ, JFL, JFM, JFP, JGS, JHI, JHW, JHX, JLW, JMG, JXM, KLI, KLS, KLT, KXS, KXT, LCD, LCM, LCP, LCR, LDJ, LDP, LEG, DHX, LFX, LGD, LJC, MRR, MSJ, MSW
Device Description
The SYNCHRON LXi 725 System combines the SYNCHRON LX20 PRO 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 LX20 PRO modules according to programming requirements. The LX20 PRO and Access 2 systems then deliver samples to the appropriate reaction vessel along with reagents and reaction constituents. The LX20based console functions as the single user interface for managing routine operations such as sample programming, results management, and QC functions.
The LXi system provides analysis of up to 65 analytes per sample, operating in conjunction with the existing reagents, calibrators, and controls designed for use with the LX20 PRO and Access 2 analyzers. The instrument features bar code identification of samples and reagents, Closed Tube Sampling (CTS), and obstruction detection and correction capability. LXi system components include the LX20 PRO 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 LXi configuration incorporates the following upgrades to the LX20 PRO System:
Closed Tube Aliquotter (CTA) Module 1.
The CTA serves as the connector between the Access 2 and LX20 PRO systems. The CTA module performs sample identification, aliquot preparation, and sample routing to programming requirements. The CTA uses disposable aliquot vessels for Access 2 sampling. The key hardware components include a laser bar code reader, sample rack shuttle, cap piercer, aliquot probe, sample wheel, wash station, and gantry.
-
Access 2 Immunochemistry Module (previously reviewed/cleared under K922823)
The Access 2 analyzer expands the chemistry menu of the LX20 PRO System. An additional serial communications line allows remote control of the Access 2 instrument through the LX20-based console. -
Hardware Modifications
The LX20 PRO sample rack shuttle and instrument covers have been modified to accommodate the CTA and Access 2 modules and to visually integrate the system.
Software Modifications
The LXi System utilizes LX20 operating software version 3.0. Version 3.0 contains the information necessary to configure, order, and report results for Access 2 tests.
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
Not Found
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)
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.
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).
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.
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
510(k) Summary SYNCHRON LX®i 725 System
1.0 Submitted By:
Mary Beth Tang Requlatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted
September 12, 2002
3.0 Device Name(s):
- 3.1 Proprietary Names: SYNCHRON LX®i 725 System
- 3.2 Classification Names: Discrete photometric chemistry analyzer for clinical use [862.2160]
4.0 Legally Marketed Device
The SYNCHRON LXi 725 System claims substantial equivalence to the SYNCHRON LX®20 PRO System currently in commercial distribution (Docket Number K011213).
5.0 Device Description
The SYNCHRON LXi 725 System combines the SYNCHRON LX20 PRO 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 LX20 PRO modules according to programming requirements. The LX20 PRO and Access 2 systems then deliver samples to the appropriate reaction vessel along with reagents and reaction constituents. The LX20based console functions as the single user interface for managing routine operations such as sample programming, results management, and QC functions.
The LXi system provides analysis of up to 65 analytes per sample, operating in conjunction with the existing reagents, calibrators, and controls designed for use with the LX20 PRO and Access 2 analyzers. The instrument features bar code identification of samples and reagents, Closed Tube Sampling (CTS), and obstruction detection and correction capability. LXi system components include the LX20 PRO 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.
1
The LXi configuration incorporates the following upgrades to the LX20 PRO System:
Closed Tube Aliquotter (CTA) Module 1.
The CTA serves as the connector between the Access 2 and LX20 PRO systems. The CTA module performs sample identification, aliquot preparation, and sample routing to programming requirements. The CTA uses disposable aliquot vessels for Access 2 sampling. The key hardware components include a laser bar code reader, sample rack shuttle, cap piercer, aliquot probe, sample wheel, wash station, and gantry.
2. Access 2 Immunochemistry Module (previously reviewed/cleared under K922823)
The Access 2 analyzer expands the chemistry menu of the LX20 PRO System. An additional serial communications line allows remote control of the Access 2 instrument through the LX20-based console.
3. Hardware Modifications
The LX20 PRO sample rack shuttle and instrument covers have been modified to accommodate the CTA and Access 2 modules and to visually integrate the system.
Software Modifications ধ,
The LXi System utilizes LX20 operating software version 3.0. Version 3.0 contains the information necessary to configure, order, and report results for Access 2 tests.
6.0 Intended Use
The SYNCHRON LX®i 725 System combines the SYNCHRON LX®20 PRO analyzer and the Access®2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliguotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements.
The SYNCHRON LX20 PRO 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).
7.0 Comparison to the Predicate
The SYNCHRON LX20 PRO system has been upgraded to an LXi system through 1) modifications to the sample rack shuttle and instrument covers. 2) the addition of a preanalytical CTA unit and an Access 2 Immunoassay analyzer, and, 3) a software update to version 3.0. There is also a name change to LXi 725 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-104 Brea, CA 92822-8000
Primary Contact: Mary Beth Tang, Regulatory Affairs Specialist Telephone: (714) 961-3777 FAX: (714) 961-4123 E-mail: mtanq@beckman.com
Secondary Contact: Annette Hellie, Requlatory Affairs Manager Telephone: (714) 993-8767 FAX: (714) 961-4123
2.0 Sponsor Address/FDA Registration Number
Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Establishment Registration No. 2050012
3.0 Product Name/Classification Name and Number
Proprietary Names
SYNCHRON LX®i 725 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-104 Box 8000 Brea, CA 92822-8000
OCT 0 4 2002
Re: K023049
Trade/Device Name: SYNCHRONLX®I 725 System Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: Class II Product Code: JGS; CHH, CDZ, CEO, DIH, JHB, JIF, JIY, JMO, CDD, CDP, CDQ, CEC, CEE, CEK, CEM, CFJ, CFR, CGA, CGR, CGS, CGX, CGZ, CIN, CJE, CJW, CZP, DCF, DCK, DDC, DDG, DDG, DDR, DFT, DGC, DHR, DIO. DIS, DJG, DJR, DKJ, DKZ, DLZ, DMT, GTQ, JFJ, JFL, JFM, JFP, JGS, JHI, JHW, JHX, JLW, JMG, JXM, KLI, KLS, KLT, KXS, KXT, LCD, LCM, LCP, LCR, LDJ, LDP, LEG, DHX, LFX, LGD, LJC, MRR, MSJ, MSW Dated: September 12, 2002 Received: September 13, 2002
Dear Ms. Tang:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2.
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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
page 1 of 1
510(k) Number (if known):
Device Name:
Indications for Use:
The SYNCHRON LX®i 725 System combines the SYNCHRON LX®20 PRO analyzer and the Access® 2 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a Closed Tube Aliguotter (CTA) unit. The CTA functions as a sample processing manager by aliquotting and routing samples to the Access 2 and/or LX20 PRO analyzer according to programming requirements.
The SYNCHRON LX20 PRO 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 chemisiries 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).
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023049
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96