(22 days)
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).
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 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: 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.
The provided text describes the SYNCHRON LX®i 725 System, a clinical chemistry analyzer, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study proving that the device meets those criteria in the way a diagnostic device approval typically would.
The document is a 510(k) summary for a Special 510(k) submission, which focuses on device modifications to an already cleared device. This type of submission often relies on a high-level statement of "performance data from validation testing supports equivalency" rather than presenting detailed studies with acceptance criteria and results for each modification.
Therefore, for many of your requested items, the answer will be that the information is not available in the provided text.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document states, "Performance data from validation testing supports equivalency," but does not provide specific acceptance criteria (e.g., accuracy, precision targets) or detailed performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in the provided text. The document does not specify the sample size used for any testing, nor does it mention the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not available in the provided text. This device is a clinical chemistry analyzer. The "ground truth" for such devices typically refers to the accuracy of the measurements compared to established reference methods or known concentrations, not expert consensus as would be used for image-based diagnostics. The document does not detail how the ground truth for evaluation was established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not available in the provided text. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are making subjective interpretations (e.g., radiology studies). For a clinical chemistry analyzer, adjudication in this sense is not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a standalone clinical chemistry analyzer, not an AI-assisted diagnostic tool that would be used by human readers for interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, indirectly. The SYNCHRON LX®i 725 System is a standalone instrument designed to perform automated clinical chemistry and immunoassay tests. Its "performance" is inherently standalone, as it generates results without direct human interpretive intervention beyond setup and quality control. The document implies that validation testing (which would assess standalone performance) was conducted to support its equivalency.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated, but implicitly related to reference methods or known concentrations. For a clinical chemistry analyzer, the "ground truth" for its measurements would typically be established through:
- Comparison to recognized reference methods.
- Testing with certified reference materials or samples with known analyte concentrations.
- Comparisons to the predicate device, assuming the predicate's measurements are considered accurate ground truth.
The document does not detail the specific ground truth methodology used for its validation testing.
8. The sample size for the training set
- Not applicable / Not available in the provided text. This device is a measurement instrument, not a machine learning algorithm that requires a "training set" in the conventional sense. While it has software that controls its operation, it's not a deep learning model trained on a large dataset of patient samples to learn patterns. Any internal calibration or algorithm development would not typically refer to a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As explained above, this device does not utilize a "training set" in the context of machine learning.
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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.
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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.
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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.
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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.
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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
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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
§ 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.