The ACCELERATOR APS (Automated Processing Systems) is a modular system designed to automate pre-analytical processing, sample handling, and processing in the clinical laboratory. The system consolidates multiple analytical instruments into a unified workstation by employing a common sample processing capability.

The ARCHITECT c8000 System is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The ARCHITECT c8000 System also has a solid state Ion-Selective Electrode module, utilizing potentiometry, for electrolyte determinations for Sodium, Potassium and Chloride.

Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Device Description

The ACCELERATOR APS (Automated Processing Systems) is a modular system designed to automate pre-analytical sample processing, sample handling, and processing in the clinical laboratory. The system consolidates multiple analytical instruments into a unified workstation by employing a common sample processing capability. The workcell software provides for workload management, sample order management, and instrument operational status monitoring. This is accomplished through communication connections between the workcell, analyzers, and LIS (laboratory information systems) or middleware.

The ACCELERATOR APS performs the following pre and post-analytical functions.

Sample bar code identification (previously performed by the analyzer)
Sample transport and tracking
Sample centrifugation (Optional functionality)
Sample de-capping (Optional functionality)
Tube sealing (Optional functionality)
Sample Storage and Retrieval (Optional functionality)

The ARCHITECT Family of Instruments test instructions and test results for each sample are not processed through the ACCELERATOR APS.

The following analyzers have been validated for use with the ACCELERATOR APS.

ARCHITECT cSystems (c8000 and c16000)
ARCHITECT i2000
ARCHITECT i2000sr

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ACCELERATOR APS, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Representative Method	Minimum Number of Specimens	Correlation Coefficient (Acceptance)	Correlation Coefficient (Reported)	Slope (Acceptance)	Slope (Reported)	Mean % Bias (Acceptance)	Mean % Bias (Reported)
Sodium	57	≥ 0.975	0.9941	0.95-1.05	0.99	≤ 3% @ 120-150 mmol/L	0.03
Potassium	57	≥ 0.975	0.9999	0.95-1.05	0.99	≤ 3% @ 3.0-6.0 mmol/L	-0.09
Chloride	58	≥ 0.975	0.9986	0.95-1.05	0.98	≤ 3% @ 90-120 mmol/L	-0.30

2. Sample Size and Data Provenance

Sample Size for Test Set:
- Sodium: 58 specimens
- Potassium: 58 specimens
- Chloride: 58 specimens
Data Provenance: Not explicitly stated. The document refers to a "method correlation comparison study" using "specimens," implying de-identified clinical samples, but does not specify their origin (e.g., country) or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this particular study. The study focuses on the analytical performance comparison between two instrument configurations (standalone vs. integrated with ACCELERATOR APS) for measuring specific analytes (Sodium, Potassium, Chloride). The "ground truth" in this context is the measurement obtained from the predicate device (standalone ARCHITECT c8000), not an expert interpretation of images or clinical outcomes. Therefore, no experts were used to establish ground truth in the traditional sense of diagnostic accuracy studies.

4. Adjudication Method for the Test Set

Not applicable. As the study is an analytical method comparison, there is no need for adjudication as one would find in studies involving human interpretation or subjective assessments. The comparison is objective, based on quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not an MRMC study. The ACCELERATOR APS is an automated pre-analytical and sample handling system, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Yes, in essence. The entire study is a standalone performance comparison of the device itself (ACCELERATOR APS integrated with ARCHITECT c8000) against a predicate device (standalone ARCHITECT c8000). The comparison evaluates the analytical performance of the integrated system in isolation, without direct human intervention in the measurement process (beyond initial sample loading and system operation). The performance metrics (correlation, slope, bias) assess the algorithm's (or system's) ability to produce results comparable to the predicate.

7. Type of Ground Truth Used

Predicate Device Measurement: The "ground truth" for comparison was the analytical measurement of Sodium, Potassium, and Chloride obtained from the standalone ARCHITECT c8000 analyzer. This served as the reference against which the ACCELERATOR APS integrated system's results were compared to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. The ACCELERATOR APS is a hardware and software system for automating laboratory processes, not a machine learning model that requires a "training set" in the conventional sense. The system's functionality is based on predefined automation sequences and analytical principles, not learned patterns from data.

9. How Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is not relevant.

Summary

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K093318

FEB 1 9 2010

510(k) Summary

Submitter's name/address

Abbott Laboratories 1920 Hurd Drive LC-2, MS 1-8 Irving, Texas 75038

Date of Preparation of this Summary: Device Trade or Proprietary Name: Device Common Name:

Classification Number/Class:

Contact Person

Mark Littlefield Regulatory Affairs Manager Abbott Laboratories (972) 518-6062 FAX (972) 518-7479

February 11, 2010

ACCELERATOR APS

APS

JQP, Class I (APS) JJE, Class I (ARCHITECT) JGS, CEM, CGZ, Class II (Sodium, Potassium, Chloride)

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K093318

Idcntification of Predicate Device:

Predicate Instrument orAssay	510(k) Number	Product Code
ARCHITECT c8000 System	K980367/A002	JJE
Clinical Chemistry ICT -Sodium, Potassium, Chloride	K980367	JGS,CEM,CGZ
ADVIA Centaur withStreamLAB AnalyticalWorkcell	K082638	JJE

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Description:

The following is a brief description of the ACCELERATOR APS System.

ACCELERATOR APS Modules

The ACCELERATOR APS performs the following pre and post-analytical functions.

. Sample bar code identification (previously performed by the analyzer)
Sample transport and tracking �
Sample centrifugation (Optional functionality) �
Sample de-capping (Optional functionality) .
Tube sealing (Optional functionality) ●
Sample Storage and Retrieval (Optional functionality) .

The ARCHITECT Family of Instruments test instructions and test results for each sample are not processed through the ACCELERATOR APS.

The following analyzers have been validated for use with the ACCELERATOR APS.

· ARCHITECT cSystems (c8000 and c16000)
- ARCHITECT i2000 .
- ARCHITECT i2000sr �

Intended Use:

The ACCELERATOR APS is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidation of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.

Substantial Equivalence:

The substantial equivalence will be demonstrated through a Method Comparison study between a standalone ARCHITECT c8000 analyzer and an ARCHITECT c8000 analyzer

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integrated to the ACCELERATOR APS system, utilizing the same specimens uniquely labelcd with individual sample tube barcode labels for sample identification (SID).

The substantial equivalence testing was conducted utilizing the ARCHITECT c8000 ICT Module for the electrolytes of Sodium, Potassium and Chloride.

ProductFunctionality	Predicate Device:ARCHITECT c8000 withembedded ICT Module	Test Device:ARCHITECT c8000 withembedded ICT Moduleand ACCELERATOR APS
Intended Use	The Abbott ARCHITECTSystem is intended for invitro diagnostic use only.The Abbott ARCHITECTSystem is designed toperform automated:Chemistry tests, utilizingphotometric andpotentiometric technology.Immunoassay tests,utilizing CMIA(ChemiluminescentMicroparticle assay)detection technology.	Same, with automated pre-analytical sampleprocessing and transportingto the ARCHITECTanalyzer.
Principle of Operation	ARCHITECT c Systemsutilize photometric andpotentiometric technologyfor analyte detection.ARCHITECT I Systemutilizes Chemiluminescentlabels with magnetic-microparticle solid phase,for analyte detection.	Same
Sample Containers	Primary tubes or samplecups.	Primary Tubes
ProductFunctionality	Predicate Device:ARCHITECT c8000 withembedded ICT Module	Test Device:ARCHITECT c8000 withembedded ICT Moduleand ACCELERATOR APS
Sample Aspiration	Directly from Primary tubeor sample cup presented tothe aspiration point by theARCHITECT RoboticSample Handler (RSH).	Directly from Primary tubepresented to the aspirationpoint by theACCELERATOR APStrack or spur.
Sample Handling	Directly loaded into theARCHITECT via theRobotic Sample Handler(RSH) or Local SampleHandler (LSH).	Directly loaded into theARCHITECT via the LSHfor i2000, c8000, c16000 orvia ACCELERATOR APS
Sample Pre-Analytics(centrifuge, de-cap, re-seal)	Manually centrifugedsample tubes by laboratorypersonnel	Manually centrifugedsample tubes by laboratorypersonnel or automaticallycentrifuged tubes byACCELERATOR APS
	Manually de-capped sampletubes by laboratorypersonnel	Manually de-capped sampletubes by laboratorypersonnel or automaticallyde-capped tubes byACCELERATOR APS
	Manually re-sealed sampletubes by laboratorypersonnel	Manually re-sealed sampletubes by laboratorypersonnel or automaticallyre-sealed tubes byACCELERATOR APS
Sample Transportation	External to analyzer: bylaboratory personnel.Internal to analyzer: byRobotic Sample Handler(RSH) or Local SampleHandler (LSH)	External to analyzer: byAPS transport carriersidentified on the system byRFID tags.Internal: N/A, samplespresented to analyzer viaACCELERATOR APS foraspiration.
ProductFunctionality	Predicate Device:ARCHITECT c8000 withembedded ICT Module	Test Device:ARCHITECT c8000 withembedded ICT Moduleand ACCELERATOR APS
Sample Identification frombar coded tubes	Bar coded sample tubesread directly by analyzerbar code reader.	Bar coded sample tubesread directly by analyzerwhen placed on LSH, orsample bar code read byACCELERATOR APS andelectronically transferred tothe ARCHITECT analyzerwhen presented at theaspiration point.
Sample Storage/Retrieval	Manually stored andretrieved by laboratorypersonnel	Manually stored andretrieved by laboratorypersonnel or automaticallystored/retrieved byACCELERATOR APS
Test Orders	Unidirectional fromLaboratory InformationSystem (LIS) ormiddleware to analyzer	Same
Test results	Unidirectional toLaboratory InformationSystem (LIS) ormiddleware from analyzer	Same
LAS Communication	N/A	ARCHITECT softwarecommunicates withACCELERATOR APS viaLAS interface.

Similarities and Difference Table to Predicate Device: ARCHITECT c8000

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Similarities and Difference Table to Predicate Device: StreamLAB

ProductFunctionality	Predicate Device:StreamLAB	Test Device:ACCELERATOR APS
Sample Bar CodeIdentification	Yes, electronicallytransferred to the analyzer	Same
Sample Transport andTracking	Yes	Same
Sample Centrifugation	Yes, Optional Functionality	Same
Sample De-capping	Yes, Optional Functionality	Same
Tube Sealing	Yes, Optional Functionality	Same
Sample Storage (optional)	Not Available	Sample Storage andRetrieval Module, OptionalFunctionality

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Performance Characteristics:

The method correlation comparison study was conducted between a standalone ARCHITECT c8000 analyzer and an ARCHITECT c8000 analyzer integrated with the ACCELERATOR APS system yielded the following results for the Sodium, Potassium and Chloride assays.

RepresentativeMethod	Number ofSpecimens	CorrelationCoefficient	Slope	Y-axisIntercept	Mean %Bias
Sodium	58	0.9941	0.99	1.75	0.03
Potassium	58	0.9999	0.99	0.03	-0.09
Chloride	58	0.9986	0.98	1.32	-0.30

Least Square Analysis

Passing - Bablok Analysis

RepresentativeMethod	Number ofSpecimens	CorrelationCoefficient	Slope	Y-axisIntercept	Mean %Bias
Sodium	58	0.9941	0.99	1.75	0.03
Potassium	58	0.9999	0.99	0.02	-0.09
Chloride	58	0.9986	0.98	1.23	-0.30

Acceptance Criteria

RepresentativeMethod	MinimumNumber ofSpecimens	CorrelationCoefficient	Slope	Mean % Bias
Sodium	57	$\geq$ 0.975	0.95-1.05	$\leq$ 3%@ 120-150 mmol/L
Potassium	57	$\geq$ 0.975	0.95-1.05	$\leq$ 3%@ 3.0-6.0 mmol/L
Chloride.	58	$\geq$ 0.975	0.95-1.05	$\leq$ 3%@ 90-120 mmol/L

Conclusion:

The data demonstrates that the performance between a standalone ARCHITECT c8000 and an ARCHITECT c8000 integrated to an ACCELERATOR APS are substantially equivalent.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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.

Abbott Laboratories c/o Mark Littlefield Regulatory Affairs, Manager 1920 Hurd Drive, LC-2, MS 1-8 Irving, TX 75038

Re: K093318

Trade/Device Name: ACCELERATOR APS Regulation Number: 21 CFR Sec. - 862.1600 Regulation Name: Potassium test system. Regulatory Class: II Product Code: CEM, CGZ, JGS, JJE, JQP Dated: January 5, 2010 Received: January 6, 2010

Dear: Mr. Littlefield:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

· Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB 1 9 2010

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, 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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Indication for Use

510(k) Number (if known): K093318

Device Name: ACCELERATOR APS

Indication For Use:

The ARCHITECT c8000 System is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The ARCHITECT c8000 System also has a solid state lon-Selective Electrode module, utilizing potentiometry, for electrolyte determinations for Sodium, Potassium and Chloride.

Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic. Device Evaluation and Safety

510(k)k093318_____________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 862.1600 Potassium test system.

(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.