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 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).

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.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the UniCel® DxC 600i System.

Important Note: The provided document is a 510(k) summary for a medical device – a clinical chemistry and immunoassay analyzer. This type of device is very different from an AI/ML-driven diagnostic tool. Therefore, many of the requested fields (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC study," "stand-alone study," "Training set sample size," and "How ground truth for training set was established") are not applicable in the context of this device. The document describes an instrument system that performs established chemical and immunological assays, not an AI model that interprets images or other complex data.

The "acceptance criteria" for such a system typically relate to its analytical performance (e.g., accuracy, precision, linearity, limits of detection) for each assay it performs, as compared to its predicate device or established standards. The document states "Performance data from validation testing supports equivalency," implying that these analytical performance characteristics were measured and met the expected standards for substantial equivalence. However, specific numerical acceptance criteria and detailed performance results are not explicitly provided in this 510(k) summary. These details would typically be found in the full 510(k) submission, not the summary.

1. Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria and detailed performance statistics for the UniCel® DxC 600i System are not explicitly detailed in this 510(k) summary. The summary states that "Performance data from validation testing supports equivalency" to the predicate device (SYNCHRON LXi 725 System). For a device like this, acceptance criteria would typically involve demonstrating:

Accuracy/Correlation: How well the results from the new device correlate with the predicate device or a reference method for various analytes across their reportable ranges.
Precision/Reproducibility: The consistency of results when the same sample is tested multiple times.
Linearity/Dilution Linearity: The ability of the system to accurately measure samples across a range of concentrations.
Limit of Detection/Quantitation: The lowest concentration of an analyte the system can reliably detect/quantify.
Interference: Lack of significant interference from common substances in biological fluids.
Carryover: Minimal transfer of analyte from a high-concentration sample to a subsequent low-concentration sample.

Since these specific numerical performance metrics are not given in the summary, the table below reflects the general statement provided.

Acceptance Criteria Category	Reported Device Performance	Comments
Overall Performance	"Performance data from validation testing supports equivalency."	This general statement implies that the device met all necessary analytical performance criteria for its intended use, demonstrating substantial equivalence to its predicate for all listed assays. Specific numerical performance data (e.g., accuracy, precision, linearity for each analyte) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not explicitly state the sample sizes used for the test sets or the data provenance (e.g., country of origin, retrospective/prospective). "Validation testing" is mentioned, which would involve testing various samples (e.g., patient samples, spiked samples, control materials) to assess the device's analytical performance.

Sample Size for Test Set: Not specified in the provided summary.
Data Provenance: Not specified in the provided summary. It typically involves samples relevant to the diverse populations encountered in clinical laboratories.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This question is Not Applicable (N/A) for this type of device.

For a clinical chemistry and immunoassay analyzer, "ground truth" for analytical performance studies is established by:

Reference Methods: Comparing the device's results to a recognized, highly accurate reference method (e.g., gas chromatography-mass spectrometry for drugs, isotope dilution mass spectrometry, or certified reference materials).
Trueness/Accuracy Studies: Using samples with known, verified concentrations (e.g., certified reference materials, proficiency testing samples).
Clinical Correlation: Assessing the device's results in the context of clinical diagnoses, but this is usually a secondary validation step, not the primary means of establishing "ground truth" for analytical performance.

There are no "experts" in the sense of human readers/interpreters establishing a consensus for diagnostic outcomes from the device's raw signals. The device itself is designed to quantitatively measure analytes from biological samples.

4. Adjudication Method for the Test Set

This question is Not Applicable (N/A) for this type of device.

Adjudication methods (like 2+1, 3+1) are employed when human interpreters are involved in labeling or assessing complex data (e.g., medical images). For a chemistry analyzer, the "ground truth" is determined by objective analytical measurements or reference methods, not subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with/without AI Assistance

This question is Not Applicable (N/A) for this type of device.

An MRMC study is relevant for interpreting diagnostic tests where human readers' performance is being evaluated, especially with AI assistance. The UniCel® DxC 600i System is an automated instrument performing quantitative assays; it does not involve human interpretation of complex data that would be "assisted" by AI in the conventional MRMC sense.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is Not Applicable (N/A) in the context of an AI algorithm, as this device itself is the standalone "algorithm" (i.e., the automated analytical process).

The device is designed to operate autonomously, executing predefined protocols to measure analytes. Its performance is inherent in its design and operation; there isn't a separate "algorithm" being evaluated beyond the instrument's overall analytical function. The performance data mentioned in the summary "supports equivalency," implying that the instrument's output by itself was evaluated against established benchmarks or the predicate device.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" for analytical performance studies typically involves:

Reference Methods: Highly accurate, validated analytical methods used to determine true analyte concentrations.
Certified Reference Materials: Samples with precisely known concentrations of analytes.
Predicate Device Comparison: Used to demonstrate substantial equivalence by showing equivalent performance to an already legally marketed device for the same assays. The summary explicitly states, "Performance data from validation testing supports equivalency," indicating this was a primary method.
Split Samples: Testing the same biological samples on both the new device and the predicate or reference method.

8. The Sample Size for the Training Set

This question is Not Applicable (N/A) for this type of device, as it is not an AI/ML system that requires a "training set."

The development and "calibration" of an instrument like this involve extensive engineering, chemical/biochemical optimization, and analytical validation. It's not "trained" on data in the way a machine learning model is.

9. How the Ground Truth for the Training Set Was Established

This question is Not Applicable (N/A) for this type of device. As explained above, there is no "training set" in the context of AI/ML. The device's operational parameters and assay specifications are established through chemical and engineering principles, extensive experimentation, and internal validation processes by the manufacturer.

Summary

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FEB 2 7 2006

K060256

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 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 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.

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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

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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

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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

K060256

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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

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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

<060256

{9}------------------------------------------------

510(k) Number (if known): K960485, K060256

Device Name: SYNCHRON® Systems Iron (FE) Reagent

Indications for Use:

FE reagent, when used in conjunction with SYNCHRON LX® Systems, UniCel® DxC 600/800 Systems and SYNCHRON® Systems FE/IBCT Calibrator Kit, is intended for the quantitative determination of fron in human serum or heparinized plasma.

Alterations in iron and total iron binding capacity levels result from changes in iron intake, absorption, storage, and release mechanisms. Such changes are indicative of a wide range of dysfunctions including anemias, nephrosis, cirrhosis and hepatitis. Both iron and total iron binding capacity measurements are important for definitive diagnosis because they are interrelated. Tietz has presented a summary of these relationships and the patterns of iron/total iron binding capacity associated with various disease states.

510(k) Number (if known): K955644, K060256

Device Name: SYNCHRON® Systems Gentamicin (GEN) Reagent

Indications for Use:

GEN reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s) and SYNCHRON® Systems Drug Calibrator 3 Plus, is intended for quantitative determination of Gentamicin concentration in human serum or plasma.

Gentamicin is an antibiotic used to treat serious gram-negative bacterial infections. Gentamicin therapy is monitored for effectiveness of the dose and possible nephrotoxicity.

510(k) Number (if known): K965108, K060256

Device Name: SYNCHRON® Systems Immunoglobulin M (IGM) Reagent

Indications for Use:

la-M reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 600/800 System(s) and SYNCHRON® Systems CAL 1, is intended for quantitative determination of Immunoqlobulin M concentration in human serum or plasma.

Measurements of immunoglobulin M are used in the diagnosis and treatment of immune deficiency states, protein-losing conditions, Waldenstrom's macroglobinemia, chronic infections, and liver disease.

Carol Benson

K060256

{10}------------------------------------------------

510(k) Number (if known): K043556, K060256

Device Name: SYNCHRON® Systems Benzodiazepine (BNZG) Reagent

Indications for Use:

indications for onjunction with SYNCHRON LX" System(s), Unicel" DrC 600800 BNZG Teagent, when used in oonjanon Drugs of Abuse Testing (DAT) Urine Calibrators, is System(s) and OTNOTHON - Gyotonio of Benzodiazepine in human urine at a cutoff value of 200 ng/mL (oxazepam).

The BNZG assay provides a rapid screening procedure for determining the presence of the The DNZO assory provides only a preliminary analytical result; a positive result by this analyte in unne. This test provides only encepted non-immunological method such as assay should be commind by any and in general (GC), or gas chromatography/mass നിന്നീ Tayer Chromatography (TEO), Gus Onformatography (GD), Or Greence (GC/MS), Reference
Spectrometry (GC/MS). GC/MS is the preferred confirmatory

Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

510(k) Number (if known): K042459, K060256

Device Name: SYNCHRON® Systems Hemoglobin A1c (HbA1c2) Reagent

Indications for Use:

The Hemoglobin A1c2 (HbA1c2) reagent, when used in conjunction with SYNCHRON LX The Themogiobili ATC2 (600/800 System(s) and SYNCHRON® Systems HbA1c2 Calibrators, is intended for the quantitative determination of hemoglobin A1c (HbA1c2) concentration as a percentage of total hemoglobin in human whole blood.

Measurement of hemoglobin A1c is accepted as a method to measure long-term glucose control in patients with diabetes mellitus (a chronic disorder associated with disturbances in carbohydrate, fat, and protein metabolism and characterized by hyperglycemia). Determination of hemoglobin A1c provides an important diagnostic tool for monitoring the efficiency of dietary control and therapy during treatment of diabetes mellitus.

510(k) Number (if known): K042281, K060256

Device Name: Access® HYPERsensitive hTSH Assay

Indications for Use:

The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and / or 2nd generation (Fast hTSH) results.

Carol Benson

K060256

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510(k) Number (if known): K023480, K060256

Device Name: Access® Total βhCG Assay

Indications for Use:

The Access Total βhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total (ShCG assay is indicated) for use with palients where an early detection of pregnancy status is desired.

510(k) Number (if known): K955434, K060256

Device Name: Access® Ferritin Assay

Indications for Use:

The Access Ferritin assay is a paramagnetic particle, chemiluminescunt immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

510(k) Number (if known): K052082, K060256

Device Name: Access® Folate Assay

Indications for Use:

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

K060256

Regulation Number and Section

§ 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.