(119 days)
Not Found
No
The summary describes an automated laboratory system for sample processing and analysis, focusing on automation, sample handling, and integration with existing analyzers and LIS. There is no mention of AI, ML, image processing, or any learning algorithms. The performance studies focus on method correlation, which is standard for comparing analytical systems, not AI/ML performance metrics.
No
The device is an automated system for pre-analytical processing, sample handling, and diagnostic analysis in a clinical laboratory. It measures various analytes to aid in diagnosis, rather than providing therapy.
Yes
The ARCHITECT c8000 System measures analytes like Sodium, Potassium, and Chloride, which are explicitly stated as being used in the "diagnosis and treatment diseases involving electrolyte imbalance." The ACCELERATOR APS supports this system, making the combined setup serve a diagnostic purpose.
No
The device description explicitly mentions hardware components and functions such as sample transport, centrifugation, de-capping, tube sealing, storage, and retrieval, in addition to the software for workload management and communication.
Based on the provided text, the ARCHITECT c8000 System is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The text explicitly states the ARCHITECT c8000 System is a "discrete photometric chemistry analyzer for clinical use" and is "intended for use in conjunction with certain materials to measure a variety of analytes". It also mentions its use for "Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance." This clearly indicates it's used to perform tests on samples taken from the human body to provide information for diagnosis or treatment.
- Device Description: It describes the system performing analytical procedures like pipetting, heating, and measuring color intensity, which are typical steps in in vitro diagnostic testing.
- Performance Studies: The inclusion of performance studies comparing the system's results for Sodium, Potassium, and Chloride assays further supports its role in generating diagnostic data.
The ACCELERATOR APS (Automated Processing Systems), while used in a clinical laboratory setting and handling samples, is described as a system to "automate pre-analytical processing, sample handling, and processing". It performs functions like sample identification, transport, centrifugation, etc. The text also states that "The ARCHITECT Family of Instruments test instructions and test results for each sample are not processed through the ACCELERATOR APS." This suggests the ACCELERATOR APS is a laboratory automation system that supports the IVD process but is not the device that performs the diagnostic test itself.
Therefore, the ARCHITECT c8000 System fits the definition of an IVD, while the ACCELERATOR APS appears to be a laboratory automation system that integrates with IVD devices.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JQP, JJE, JGS, CEM, CGZ
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method correlation comparison study was conducted between a standalone ARCHITECT c8000 analyzer and an ARCHITECT c8000 analyzer integrated with the ACCELERATOR APS system for Sodium, Potassium and Chloride assays.
Sample Size: 58 specimens for each assay type (Sodium, Potassium, Chloride).
Key results:
Least Square Analysis:
- Sodium: Correlation Coefficient = 0.9941, Slope = 0.99, Y-axis Intercept = 1.75, Mean % Bias = 0.03
- Potassium: Correlation Coefficient = 0.9999, Slope = 0.99, Y-axis Intercept = 0.03, Mean % Bias = -0.09
- Chloride: Correlation Coefficient = 0.9986, Slope = 0.98, Y-axis Intercept = 1.32, Mean % Bias = -0.30
Passing - Bablok Analysis:
- Sodium: Correlation Coefficient = 0.9941, Slope = 0.99, Y-axis Intercept = 1.75, Mean % Bias = 0.03
- Potassium: Correlation Coefficient = 0.9999, Slope = 0.99, Y-axis Intercept = 0.02, Mean % Bias = -0.09
- Chloride: Correlation Coefficient = 0.9986, Slope = 0.98, Y-axis Intercept = 1.23, Mean % Bias = -0.30
The data demonstrates that the performance between a standalone ARCHITECT c8000 and an ARCHITECT c8000 integrated to an ACCELERATOR APS are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient, Slope, Y-axis Intercept, Mean % Bias.
Acceptance Criteria:
- Correlation Coefficient: >= 0.975 for Sodium, Potassium, Chloride.
- Slope: 0.95-1.05 for Sodium, Potassium, Chloride.
- Mean % Bias:
§ 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.
0
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 or
| Assay | 510(k) Number | Product Code |
|---|---|---|
| ARCHITECT c8000 System | K980367/A002 | JJE |
| Clinical Chemistry ICT - | ||
| Sodium, Potassium, Chloride | K980367 | JGS,CEM,CGZ |
| ADVIA Centaur with | ||
| StreamLAB Analytical | ||
| Workcell | K082638 | JJE |
1
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
2
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
Functionality | Predicate Device:
ARCHITECT c8000 with
embedded ICT Module | Test Device:
ARCHITECT c8000 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 CMIA
(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.
ARCHITECT I System
utilizes Chemiluminescent
labels with magnetic-
microparticle solid phase,
for analyte detection. | Same |
| Sample Containers | Primary tubes or sample
cups. | Primary Tubes |
| Product
Functionality | Predicate Device:
ARCHITECT c8000 with
embedded ICT Module | Test Device:
ARCHITECT c8000 with
embedded ICT Module
and ACCELERATOR APS |
| 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). | Directly loaded into the
ARCHITECT via the LSH
for i2000, c8000, c16000 or
via ACCELERATOR APS |
| Sample Pre-Analytics
(centrifuge, de-cap, re-seal) | Manually centrifuged
sample tubes by laboratory
personnel | Manually centrifuged
sample tubes by laboratory
personnel or automatically
centrifuged tubes by
ACCELERATOR APS |
| | Manually de-capped sample
tubes by laboratory
personnel | Manually de-capped sample
tubes by laboratory
personnel or automatically
de-capped tubes by
ACCELERATOR APS |
| | Manually re-sealed sample
tubes by laboratory
personnel | Manually re-sealed sample
tubes by laboratory
personnel or automatically
re-sealed tubes by
ACCELERATOR APS |
| Sample Transportation | External to analyzer: by
laboratory personnel.
Internal to analyzer: by
Robotic Sample Handler
(RSH) or Local Sample
Handler (LSH) | 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. |
| Product
Functionality | Predicate Device:
ARCHITECT c8000 with
embedded ICT Module | Test Device:
ARCHITECT c8000 with
embedded ICT Module
and ACCELERATOR APS |
| Sample Identification from
bar coded tubes | Bar coded sample tubes
read directly by analyzer
bar code reader. | 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 |
| LAS Communication | N/A | ARCHITECT software
communicates with
ACCELERATOR APS via
LAS interface. |
Similarities and Difference Table to Predicate Device: ARCHITECT c8000
3
.
.
4
Similarities and Difference Table to Predicate Device: StreamLAB
| 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 |
| Sample Storage (optional) | Not Available | Sample Storage and
Retrieval Module, Optional
Functionality |
5
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
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 |
Least Square Analysis
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 |
Acceptance Criteria
| Representative
Method | Minimum
Number of
Specimens | Correlation
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.
6
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
7
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,
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
8
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_____________________________________________________________________________________________________________________________________________________________