(30 days)
Not Found
No
The description focuses on standard immunoassay technology and automated processes without mentioning AI or ML algorithms for analysis or interpretation.
No
This device is an in vitro diagnostic immunoassay analyzer used to measure analytes in samples, not to treat or diagnose a disease in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" explicitly states that the device is an "Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory."
No
The device description clearly outlines a physical, bench-top system that performs chemical reactions and measures light output, indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "designed specifically for in vitro diagnostic use in a clinical laboratory."
- Device Description: The description details how the device analyzes samples (blood, etc.) to measure analytes (antigens or antibodies) using chemical reactions and light measurement. This process is characteristic of in vitro diagnostic testing.
- Care Setting: The "Intended User / Care Setting" is a "clinical laboratory," which is the typical environment for performing in vitro diagnostic tests.
The information provided clearly indicates that this device is intended to be used outside of the body to examine samples for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
Product codes
JPA
Device Description
The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in samples by: Subjecting the sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to let the reactants bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 03, 2017
Instrumentation Laboratory Co. Ms. Nikita Malladi Senior Regulatory Affairs Specialist 180 Hartwell Road Bedford, MA 01730
Re: K170314
Trade/Device Name: ACL AcuStar™ Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in-vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: January 31, 2017 Received: February 01, 2017
Dear Ms. Malladi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Leonthena R. Carrington -S
Lea Carrington, MS, MBA, MT(ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ACL AcuStar™
Indications for Use (Describe)
Automated immunoassay analyzer designed specifically for in vitro diagnostic use in a clinical laboratory. The assay analysis is based on chemiluminescent technology. The system provides results for both direct measurements and calculated parameters.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
The submission meets the criteria for a Special 510(k) under the FDA guidance "The New 510(k) Paradigm -Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications".
| Submitter's Information | Instrumentation Laboratory (IL) Co. |
|---|---|
| 180 Hartwell Road | |
| Bedford, MA 01730, USA |
| Contact Person | Nikita Malladi, Senior Regulatory Affairs Specialist
Phone: 781-674-3245
Fax: 781-861-4207
Email: nmalladi@ilww.com |
| ---------------- | ------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Preparation Date | January 31, 2017 |
|---|---|
| ------------------ | ------------------ |
| Device Trade Name | ACL AcuStar™ |
|---|---|
| ------------------- | -------------- |
| Regulatory Information | Classification: | Class II |
|---|---|---|
| Regulation No.: | 21 CFR 864.5425 | |
| Common Name: | System, Multipurpose For In Vitro Coagulation | |
| Studies | ||
| Panel: | Hematology (81) | |
| Product Code: | JPA |
| Predicate Device | ACL AcuStar: K083518 |
|---|---|
| Indications for Use / | |
| Intended Use | The ACL AcuStar is an automated immunoassay analyzer designed |
| specifically for in vitro diagnostic use in a clinical laboratory. The | |
| assay analysis is based on chemiluminescent technology. The |
system provides results for both direct measurements and
calculated parameters.
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| Device Description | The AcuStar is an automated, bench-top system for lab use that measures the analyte amount in samples by: |
|---|---|
| Subjecting the sample to reagents that cause a reaction with an antigen or antibody in the sample. Placing the cuvettes in a controlled environment to let the reactants bind into a complex. Separating out the complex from unused reactants. Treating this complex with a chemical that produces light in proportion to the analyte concentration. Measuring the light output to determine the amount of antibodies or antigens that were in the sample. |
| Description of Modification | This Special 510(k) is being submitted to update the operating system software from Windows XP to Windows 7 for the ACL AcuStar instrument. |
|---|---|
| ----------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- |
| Reason Submission Qualifies as
Special 510(k) | The submission meets the criteria for a Special 510(k) based on the
following: |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No change in indications for use or intended use No change in operating principle No change to labeled performance claims No change to hardware No change to data reduction software No change to fluidic design No change to test parameters No change to calibration No change to quality control No change to consumables No change to reagents |
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Comparison to Predicate Device (K083518):
Following is a description of the similarities and differences between the currently marketed ACL AcuStar Family (K083518) and ACL TOP Family with the Software 3.0.1 update:
| Item | Predicate Device
(K083518) | Updated Device
(with SW 3.0.1) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Trade Name | ACL AcuStar | Same |
| Indications for Use | ACL AcuStar is an automated immunoassay analyzer
designed specifically for in vitro diagnostic use in a
clinical laboratory. The assay analysis is based on
chemiluminescent technology.
The system provides results for both direct
measurements and calculated parameters. | Same |
| Physical Format | Single cartridge containing reagents | Same |
| Sample Type | Citrated Plasma or Serum (assay dependent) | Same |
| Dimensions | Height 54cm (21 ¼")
Width 87cm (34 ¼")
Depth 62cm (24 ½") | Same |
| Weight | 77.25 Kg (170.3 lbs) | Same |
| Methodology | Chemiluminescent technology | Same |
| Test Menu | Chemiluminescent immunoassays | Same |
| Software version | LR 10 | 3.0.1 |
| Operating System Software | Windows XP | Windows 7 |
Conclusion:
Based on the shared indications for use, operating principle, consumables, reagents, controls and calibrators, the ACL AcuStar with software v3.0.1 running on the Windows 7 operating system can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, ACL AcuStar.