ACCELERATOR APS

K093318 · Abbott Laboratories · CEM · Feb 19, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093318
• Device Name: ACCELERATOR APS
• Applicant: Abbott Laboratories
• Product Code: CEM · Clinical Chemistry
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1600
• Device Class: Class 2

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.

Device Story

ACCELERATOR APS is a modular laboratory automation system; consolidates multiple clinical chemistry and immunoassay analyzers into a unified workstation. Inputs: primary sample tubes with bar codes. Functions: automated sample transport, tracking, centrifugation, de-capping, tube sealing, and storage/retrieval. Operation: system communicates with analyzers and LIS/middleware for workload and order management. Output: samples presented to analyzer aspiration points; electronic transfer of sample identification to analyzers. Used in clinical laboratories; operated by laboratory personnel. Benefits: reduces manual pre-analytical steps (centrifugation, de-capping, re-sealing, transport); improves workflow efficiency and sample tracking; ensures consistent sample handling prior to analysis.

Clinical Evidence

Bench testing only. Method comparison study performed on 58 specimens comparing standalone ARCHITECT c8000 vs. ARCHITECT c8000 integrated with ACCELERATOR APS. Results: Sodium (r=0.9941, slope=0.99, bias=0.03%), Potassium (r=0.9999, slope=0.99, bias=-0.09%), Chloride (r=0.9986, slope=0.98, bias=-0.30%). All results met pre-defined acceptance criteria for correlation (>=0.975) and slope (0.95-1.05).

Technological Characteristics

Modular automation system; utilizes RFID tags for carrier tracking. Analytical module uses Ion Selective Electrode (ISE) potentiometry. Connectivity via LAS interface to LIS/middleware. Software-controlled workload management. No specific materials or sterilization standards cited.

Indications for Use

Indicated for use in clinical laboratories to automate pre-analytical sample processing, handling, and transport for electrolyte (Sodium, Potassium, Chloride) testing in patients requiring diagnosis and treatment of electrolyte imbalances.

Regulatory Classification

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.

Predicate Devices

• Abbott, Aeroset with ISE - Integrated Chip Technology (ICT) module (k980367)
• Siemens, Advia Centaur System with StreamLab Analytical Workcell (k082638)

Submission Summary (Full Text)

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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 [phone] FAX [phone]

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 or<br>Assay | 510(k) Number | Product Code |
|---------------------------------------------------------|---------------|--------------|
| ARCHITECT c8000 System | K980367/A002 | JJE |
| Clinical Chemistry ICT -<br>Sodium, Potassium, Chloride | K980367 | JGS,CEM,CGZ |
| ADVIA Centaur with<br>StreamLAB Analytical<br>Workcell | K082638 | JJE |

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### Description:

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

# ACCELERATOR APS Modules

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 �

## 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.

| Product<br>Functionality | Predicate Device:<br>ARCHITECT c8000 with<br>embedded ICT Module | Test Device:<br>ARCHITECT c8000 with<br>embedded ICT Module<br>and ACCELERATOR APS |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Abbott ARCHITECT<br>System is intended for in<br>vitro diagnostic use only.<br>The Abbott ARCHITECT<br>System is designed to<br>perform automated:<br><br>Chemistry tests, utilizing<br>photometric and<br>potentiometric technology.<br><br>Immunoassay tests,<br>utilizing CMIA<br>(Chemiluminescent<br>Microparticle assay)<br>detection technology. | Same, with automated pre-<br>analytical sample<br>processing and transporting<br>to the ARCHITECT<br>analyzer. |
| Principle of Operation | ARCHITECT c Systems<br>utilize photometric and<br>potentiometric technology<br>for analyte detection.<br><br>ARCHITECT I System<br>utilizes Chemiluminescent<br>labels with magnetic-<br>microparticle solid phase,<br>for analyte detection. | Same |
| Sample Containers | Primary tubes or sample<br>cups. | Primary Tubes |
| Product<br>Functionality | Predicate Device:<br>ARCHITECT c8000 with<br>embedded ICT Module | Test Device:<br>ARCHITECT c8000 with<br>embedded ICT Module<br>and ACCELERATOR APS |
| Sample Aspiration | Directly from Primary tube<br>or sample cup presented to<br>the aspiration point by the<br>ARCHITECT Robotic<br>Sample Handler (RSH). | Directly from Primary tube<br>presented to the aspiration<br>point by the<br>ACCELERATOR APS<br>track or spur. |
| Sample Handling | Directly loaded into the<br>ARCHITECT via the<br>Robotic Sample Handler<br>(RSH) or Local Sample<br>Handler (LSH). | Directly loaded into the<br>ARCHITECT via the LSH<br>for i2000, c8000, c16000 or<br>via ACCELERATOR APS |
| Sample Pre-Analytics<br>(centrifuge, de-cap, re-seal) | Manually centrifuged<br>sample tubes by laboratory<br>personnel | Manually centrifuged<br>sample tubes by laboratory<br>personnel or automatically<br>centrifuged tubes by<br>ACCELERATOR APS |
| | Manually de-capped sample<br>tubes by laboratory<br>personnel | Manually de-capped sample<br>tubes by laboratory<br>personnel or automatically<br>de-capped tubes by<br>ACCELERATOR APS |
| | Manually re-sealed sample<br>tubes by laboratory<br>personnel | Manually re-sealed sample<br>tubes by laboratory<br>personnel or automatically<br>re-sealed tubes by<br>ACCELERATOR APS |
| Sample Transportation | External to analyzer: by<br>laboratory personnel.<br>Internal to analyzer: by<br>Robotic Sample Handler<br>(RSH) or Local Sample<br>Handler (LSH) | External to analyzer: by<br>APS transport carriers<br>identified on the system by<br>RFID tags.<br>Internal: N/A, samples<br>presented to analyzer via<br>ACCELERATOR APS for<br>aspiration. |
| Product<br>Functionality | Predicate Device:<br>ARCHITECT c8000 with<br>embedded ICT Module | Test Device:<br>ARCHITECT c8000 with<br>embedded ICT Module<br>and ACCELERATOR APS |
| Sample Identification from<br>bar coded tubes | Bar coded sample tubes<br>read directly by analyzer<br>bar code reader. | Bar coded sample tubes<br>read directly by analyzer<br>when placed on LSH, or<br>sample bar code read by<br>ACCELERATOR APS and<br>electronically transferred to<br>the ARCHITECT analyzer<br>when presented at the<br>aspiration point. |
| Sample Storage/Retrieval | Manually stored and<br>retrieved by laboratory<br>personnel | Manually stored and<br>retrieved by laboratory<br>personnel or automatically<br>stored/retrieved by<br>ACCELERATOR APS |
| Test Orders | Unidirectional from<br>Laboratory Information<br>System (LIS) or<br>middleware to analyzer | Same |
| Test results | Unidirectional to<br>Laboratory Information<br>System (LIS) or<br>middleware from analyzer | Same |
| LAS Communication | N/A | ARCHITECT software<br>communicates with<br>ACCELERATOR APS via<br>LAS interface. |

# Similarities and Difference Table to Predicate Device: ARCHITECT c8000

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.

.

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# Similarities and Difference Table to Predicate Device: StreamLAB

| Product<br>Functionality | Predicate Device:<br>StreamLAB | Test Device:<br>ACCELERATOR APS |
|-----------------------------------|----------------------------------------------------|-------------------------------------------------------------------|
| Sample Bar Code<br>Identification | Yes, electronically<br>transferred to the analyzer | Same |
| Sample Transport and<br>Tracking | 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 and<br>Retrieval Module, Optional<br>Functionality |

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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.

| Representative<br>Method | Number of<br>Specimens | Correlation<br>Coefficient | Slope | Y-axis<br>Intercept | Mean %<br>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

| Representative<br>Method | Number of<br>Specimens | Correlation<br>Coefficient | Slope | Y-axis<br>Intercept | Mean %<br>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

| Representative<br>Method | Minimum<br>Number of<br>Specimens | Correlation<br>Coefficient | 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 [phone]. 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 [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

CA

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 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 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_______________________________________________________________________________________________________________________________________________________________