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

Indications for 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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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k093318

B. Purpose for Submission:
The submission is to obtain clearance for The ACCELERATOR APS an accessory to clinical laboratory analyzers such as ARCHITECT c8000 analyzer. The submission uses the ARCHITECT c8000 to demonstrate ACCELERATOR barcode sample ID transmission to analyzer and analytical equivalence to manual sample introduction verses automated sample introduction on the analyzer.

C. Measurand:
Sodium, potassium and chloride

D. Type of Test:
Quantitative, ion selective electrode (ISE)

E. Applicant:
Abbott Laboratories

F. Proprietary and Established Names:
ACCELERATOR APS

G. Regulatory Information:
1. Regulation section:

| Regulation | Name | Class |
| --- | --- | --- |
| 21CFR Sec.- 862.1600: | Potassium test system. | 2 |
| 21CFR Sec.- 862.1170: | Chloride test system. | 2 |
| 21CFR Sec.- 862.1665: | Sodium test system. | 2 |
| 21CFR Sec.- 862.2160: | Discrete photometric chemistry analyzer for clinical use. | 1 |
| 21CFR Sec.- 862.2100: | Calculator/data processing module for clinical use. | 1 |

2. Product code:

| Product code | Device Name |
| --- | --- |
| CEM | Electrode, ion specific, potassium |
| CGZ | Electrode, ion-specific, chloride |
| JGS | Electrode, ion specific, sodium |
| JJE | Analyzer, chemistry (photometric, discrete), for clinical use |
| JQP | Calculator/data processing module, for clinical use |

4. Panel:
Chemistry (75)

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H. Intended Use:

1. Intended use(s):
See Indication(s) for use below.

2. Indication(s) 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 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.

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
ARCHITECT c8000 System

I. 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)

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J. Substantial Equivalence Information:

1. Predicate device name(s):
Abbott, Aeroset with ISE - Integrated Chip Technology (ICT) module (Architect is a family)
Siemens, Advia Centaur System with StreamLab Analytical Workcell

2. Predicate 510(k) number(s):
k980367, k082638 respectively

3. Comparison with predicate:
Similarities and Difference Table to Predicate Device: ARCHITECT c8000

| Product Functionality | Predicate Device: ARCHITECT c8000 with embedded ICT Module | Test Device: ARCHITECT e8000 with embedded ICT Module and ACCELERATOR APS |
| --- | --- | --- |
| Intended Use | The Abbott ARCHITECT System is intended for in vitro diagnostic use only. The Abbott ARCHITECT System is designed to perform automated: Chemistry tests, utilizing photometric and potentiometric technology. Immunoassay tests, utilizing CM1A (Chemiluminescent Microparticle assay) detection technology. | Same, with automated pre-analytical sample processing and transporting to the ARCHITECT analyzer. |
| | | |
| Principle of Operation | ARCHITECT c Systems utilize photometric and potentiometric technology for analyte detection. | Same |
| Sample Containers | Primary tubes or sample cups. | Primary Tubes |
| Sample Aspiration | Directly from Primary tube or sample cup presented to the aspiration point by the ARCHITECT Robotic Sample Handler (RSH). | Directly from Primary tube presented to the aspiration point by the ACCELERATOR APS track or spur. |
| Sample Handling | Directly loaded into the ARCHITECT via the Robotic Sample Handler (RSH) or Local Sample Handler (LSH). Manually centrifuged sample tubes by laboratory personnel. Manually de-capped sample tubes by laboratory personnel. Manually re-sealed sample tubes by laboratory personnel External to analyzer: by | Directly loaded into the ARCHITECT via the LSH or via ACCELERATOR APS |

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| Product Functionality | Predicate Device: ARCHITECT c8000 with embedded ICT Module | Test Device: ARCHITECT e8000 with embedded ICT Module and ACCELERATOR APS |
| --- | --- | --- |
| | laboratory personnel. Internal to analyzer: by Robotic Sample Handler (RSH) or Local Sample Handler (LSH) Bar coded sample tubes read directly by analyzer bar code reader. | |
| Sample Pre-Antilytics (centrifuge, de-cap, re-seal) | | Manually centrifuged sample tubes by laboratory personnel or automatically centrifuged tubes by ACCELERATOR APS |
| | | Manually de-capped sample tubes by laboratory personnel or automatically de-capped tubes by ACCELERATOR APS |
| | | Manually re-sealed sample tubes by laboratory personnel or automatically re-sealed tubes by ACCELERATOR APS |
| Sample Transportation | | External to analyzer: by APS transport carriers identified on the system by RFID tags. Internal: N/A, samples presented to analyzer via ACCELERATOR APS for aspiration. |
| Sample Identification from bar coded tubes | | Bar coded sample tubes read directly by analyzer when placed on LSH, or sample bar code read by ACCELERATOR APS and electronically transferred to the ARCHITECT analyzer when presented at the aspiration point. |
| Sample Storage Retrieval | Manually stored and retrieved by laboratory personnel | Manually stored and retrieved by laboratory personnel or automatically stored/retrieved by ACCELERATOR APS |
| Test Orders | Unidirectional from Laboratory Information System (LIS) or middleware to analyzer | Same |
| Test results | Unidirectional to Laboratory Information System (LIS) or middleware from analyzer | Same |

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| Product Functionality | Predicate Device: ARCHITECT c8000 with embedded ICT Module | Test Device: ARCHITECT e8000 with embedded ICT Module and ACCELERATOR APS |
| --- | --- | --- |
| LAS Communication | N/A | ARCHITECT software communicates with ACCELERATOR APS via LAS interface. |

Similarities and Differences Table to Predicate Device: StreamLAB - k082638

| Product Functionality | Predicate Device: StreamLAB | Test Device: ACCELERATOR APS |
| --- | --- | --- |
| Sample Bar Code Identification | Yes, electronically transferred to the analyzer | Same |
| Sample Transport and Tracking | Yes | Same |
| Sample Centrifugation | Yes, Optional Functionality | Same |
| Sample De-capping | Yes, Optional Functionality | Same |
| Tube Sealing | Yes, Optional Functionality | Same |

K. Standard/Guidance Document Referenced (if applicable):
None were referenced

L. Test Principle:
Ion Selective Electrode (ISE) utilizing potentiometry

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Provided in k980367
b. Linearity/assay reportable range:
Provided in k980367
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Provided in k980367
d. Detection limit:
Provided in k980367
e. Analytical specificity:
Provided in k980367
f. Assay cut-off:
Not applicable

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2. Comparison studies:

a. Method comparison with predicate device:

The method correlation comparison study was conducted between a stand-alone 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.

Least Square Analysis

| Representative Method | Number of Specimens | Correlation Coefficient | Slope | Y-axis Intercept | 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 |

Passing -Bablok Analysis

| Representative Method | Number of Specimens | Correlation Coefficient | Slope | Y-axis Intercept | 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 |

b. Matrix comparison: Not applicable

3. Clinical studies:

a. Clinical Sensitivity: Not applicable
b. Clinical specificity: Not applicable
c. Other clinical supportive data (when a. and b. are not applicable): Not applicable

4. Clinical cut-off: Not applicable

5. Expected values/Reference range: Provided in k980367

N. Instrument Name:

ACCELERATOR APS

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O. System Descriptions:

1. Modes of Operation:

The ACCELERATOR APS (Automated Processing Systems) workcell 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 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.

2. Software:

FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes ☐ X or No ☐

The applicant provided software documentation that supports the device was designed and developed under good software LifeCycle processes.

3. Specimen Identification:

Sample tube bar code (identification) is read by the Architect (when tubes are placed directly on the Architect); or sample tube bar code read by ACCELERATOR APS and communicated electronically to the Architect (when tubes are loaded onto ACCELERATOR APS).

4. Specimen Sampling and Handling:

The analyzer Interface module provides the path required to move sample tubes to the analyzer. If a sample tube has test requests for an analyzer, the tube carrier is moved to the analyzer for sample aspiration and processing. After sample aspiration, the sample tube is returned to the main lane of the workcell.

5. Calibration:

Provided in k980367

6. Quality Control:

Provided in k980367

P. Other Supportive Instrument Performance Characteristics Data Not Covered In

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The "Performance Characteristics" Section above:

Various functional test protocols were used to validate the barcode read and transmission capabilities for the ACCELERATOR APS/Architect system. The test protocols were found acceptable.

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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