(83 days)
The ACL TOP 700 LAS is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
The ACL TOP 700 LAS is being introduced as a new family member to the ACL TOP (K073377), with the added feature of an extra arm and hardware to interface with laboratory automation systems (LAS). A Point-in-Space design solution is utilized where the patient sample remains under the control of the laboratory automation system (i.e., the automation track) and the ACL TOP 700 LAS analyzer aspirates an aliquot for sample analysis without removing the primary container from the automation track. The instrument's system software was also modified to interface with an IM (interface module) computer, which controls the communications to the LAS system.
The provided text describes the regulatory clearance for the ACL TOP 700 LAS coagulation instrument, asserting its substantial equivalence to a predicate device (ACL TOP K073377). However, the document (a 510(k) summary) focuses on the reason for submission and comparison to predicate device, stating that testing demonstrated substantial equivalence rather than providing specific acceptance criteria and detailed study results for the new device.
Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided text, as this type of detailed study report is typically found in the full 510(k) submission, not the publicly available summary.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the given 510(k) summary. The summary states: "Testing demonstrated that the performance of the ACL TOP 700 LAS is substantially equivalent to the performance of the current legally marketed ACL TOP family (K073377)." This implies that the acceptance criteria for the new device were implicitly met by demonstrating performance equivalent to the predicate, but the specific criteria (e.g., precision, accuracy ranges) and the numerical results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the 510(k) summary. For a coagulation instrument, "ground truth" would typically relate to the accuracy and precision of its measurements compared to reference methods or established standards, rather than expert consensus on a diagnostic image.
4. Adjudication Method for the Test Set:
This information is not provided in the 510(k) summary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
This information is not provided in the 510(k) summary. MRMC studies are typical for diagnostic imaging devices where human interpretation is involved. This device is a fully automated laboratory instrument; therefore, an MRMC study is unlikely to be relevant or performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device is described as "fully automated," suggesting its performance would inherently be standalone (algorithm/instrument only). However, specific performance metrics of a standalone study are not detailed beyond the statement of substantial equivalence.
7. The Type of Ground Truth Used:
For a coagulation instrument, the "ground truth" would likely be established through reference methods, calibrated standards, and known-concentration samples. The 510(k) summary does not specify the exact type of ground truth used, but it implicitly relies on established laboratory practices for validating instrument performance.
8. The Sample Size for the Training Set:
This information is not provided in the 510(k) summary. For a coagulation instrument, "training set" might refer to data used for internal calibration or algorithm development, but it's not discussed in the context of clinical validation data in this summary.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the 510(k) summary.
Summary of Available Information from the Provided Text:
- Device Name: ACL TOP 700 LAS
- Predicate Device: ACL TOP (K073377)
- Nature of Study: A substantial equivalence demonstration (Special 510(k)) based on testing that confirmed the new device's performance is equivalent to the predicate.
- Key Change: Addition of an extra arm and hardware for interface with Laboratory Automation Systems (LAS), allowing aspiration without removing the primary container from the automation track. System software was also modified for LAS interface.
- Claim: The ACL TOP 700 LAS shares the same intended use/indications for use, analytical technology/operating principle, analytical specifications, labeled performance characteristics, analytical data reduction, software, test parameters, and uses the same consumables and racks as the predicate.
To obtain the detailed acceptance criteria and study results, one would typically need to review the full 510(k) submission available through FDA, as the summary often omits these specifics.
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SEP 2 2 2009
510(k) Summary
2091980
Applicant Contact Information:
| Applicant:Address: | Instrumentation Laboratory Co.113 Hartwell AvenueLexington, MA 02421 |
|---|---|
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Alternate Contact: | Gabriella Erdosy, Regulatory Affairs Associate |
| Phone Number: | 781-861-4571 |
| Preparation Date: | June 30, 2009 |
Device Trade Name:
ACL TOP 700 LAS
Regulatory Information:
| Regulation Section: | Coagulation Instrument (864.5400) |
|---|---|
| Classification: | Class II |
| Product Code: | GKP |
| Panel: | Hematology |
Predicate Device:
K073377 ACL TOP
Indications for Use:
The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
Reason for Submission:
The ACL TOP 700 LAS is being introduced as a new family member to the ACL TOP (K073377), with the added feature of an extra arm and hardware to interface with laboratory automation systems (LAS). A Point-in-Space design solution is utilized where the patient sample remains under the control of the laboratory automation system (i.e., the automation track) and the ACL TOP 700 LAS analyzer aspirates an aliquot for sample analysis without removing the primary container from the automation track. The instrument's system software was also modified to interface with an IM (interface module) computer, which controls the communications to the LAS system.
- The ACL TOP 700 LAS shares with the other ACL TOP family members, the same intended NOTE: use/indications for use, analytical technology/operating principle, analytical specifications, labeled performance characteristics, analytical data reduction, software, test parameters and uses the same consumables and racks.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Testing demonstrated that the performance of the ACL TOP 700 LAS is substantially equivalent to the performance of the current legally marketed ACL TOP family (K073377).
Section 5
Special 510(k): ACL TOP 700 LAS
Page 1 of 1
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Instrumentation Laboratory Co. c/o Ms. Carol Marble Regulatory Affairs Director 113 Hartwell Ave Lexington, MA 02421
SEP 2 2 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Re: K091980
Trade/Device Name: ACL TOP 700 LAS Regulation Number: 21 CFR 864,5400 . Regulation Name: Coagulation Instrument Regulatory Class: Class II Product Code: GKP Dated: August 27, 2009 Received: August 28, 2009
Dear Ms. Marble:
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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 -- Ms. Carol Marble
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
m. Chan
Maria M. Chan, PhD Director Division of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _
1091980
Device Name: ACL TOP 700 LAS
Indications for Use:
The ACL TOP 700 LAS is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
The system provides results for both direct hemostasis measurements and calculated parameters.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091980
Attachment A
K091980: ACL TOP 700 LAS
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.