(77 days)
No
The summary describes a standard automated laboratory analyzer for hemostasis testing and does not mention any AI or ML capabilities. The performance studies focus on precision and method comparison, typical for such devices, and there is no mention of training or test sets for AI/ML models.
No
The device is described as an in vitro diagnostic analyzer used for testing in a laboratory setting to assess thrombosis and hemostasis, not to treat a condition.
Yes
The device is described as an "in vitro diagnostic clinical use" analyzer, designed for "coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis," which directly implies its use in diagnosing conditions.
No
The device is described as a "bench top, fully automated, random access analyzer," which clearly indicates it is a physical hardware device, not software only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "designed specifically for in vitro diagnostic clinical use".
- Device Description: Repeats the phrase "designed specifically for in vitro diagnostic clinical use".
- Function: The device performs "coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis" using "citrated plasma samples". This is a classic example of an in vitro diagnostic test performed on a biological sample outside of the body.
- Care Setting: The intended user is a "hemostasis laboratory", which is a typical setting for IVD testing.
N/A
Intended Use / 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.
Product codes
GKP, JPA
Device Description
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.
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
hemostasis 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
Precision: Within run and total precision assessed over multiple runs (n=80) using normal and abnormal levels of control plasma.
Method Comparison: In method comparison studies evaluating citrated plasma samples, the ACL TOP and the ACL Advance (predicate device) were shown to be statistically similar. Sample sizes for each reagent type range from 93 to 205.
Key Metrics
Precision (%CV):
Antithrombin: Within Run 5.7 (Normal), 5.6 (Low Abnormal), 6.8 (High Abnormal); Total 5.8 (Normal), 6.8 (Low Abnormal), 9.1 (High Abnormal)
APTT: Within Run 1.2 (Normal), 0.9 (Low Abnormal), 0.9 (High Abnormal); Total 1.6 (Normal), 2.1 (Low Abnormal), 1.4 (High Abnormal)
D-Dimer: Within Run 4.6 (Low Control), 2.5 (High Control); Total 7.7 (Low Control), 4.5 (High Control)
Factor II: Within Run 4.2 (Normal), 4.1 (Low Abnormal), 3.8 (High Abnormal); Total 5.2 (Normal), 5.3 (Low Abnormal), 5.6 (High Abnormal)
Factor V: Within Run 4.0 (Normal), 3.0 (Low Abnormal), 3.6 (High Abnormal); Total 4.7 (Normal), 4.7 (Low Abnormal), 4.8 (High Abnormal)
Factor VII: Within Run 3.6 (Normal), 2.1 (Low Abnormal), 2.9 (High Abnormal); Total 3.9 (Normal), 3.7 (Low Abnormal), 4.4 (High Abnormal)
Factor X: Within Run 1.8 (Normal), 2.2 (Low Abnormal), 1.9 (High Abnormal); Total 2.8 (Normal), 3.4 (Low Abnormal), 3.6 (High Abnormal)
Fibrinogen-C: Within Run 7.9 (Normal), 7.7 (Low Fibrinogen); Total 8.8 (Normal), 8.4 (Low Fibrinogen)
Protein C: Within Run 2.6 (Normal), 3.0 (Low Abnormal), 3.7 (High Abnormal); Total 3.3 (Normal), 4.3 (Low Abnormal), 4.7 (High Abnormal)
Prothrombin Time (PT): Within Run 1.3 (Normal), 1.5 (Low Abnormal), 1.8 (High Abnormal); Total 1.4 (Normal), 2.7 (Low Abnormal), 3.0 (High Abnormal)
PT-Based Fibrinogen: Within Run 3.7 (Normal), 7.7 (Low Fibrinogen); Total 4.1 (Normal), 7.8 (Low Fibrinogen)
Method Comparison (Slope, Intercept, r-value):
Antithrombin: Slope 1.03, Intercept -1.418, r 0.9660
APTT: Slope 1.076, Intercept -0.380, r 0.9943
D-Dimer: Slope 1.12, Intercept -16.0, r 0.993
Factor II: Slope 0.95, Intercept -0.551, r 0.9753
Factor V: Slope 0.81, Intercept 4.742, r 0.9822
Factor VII: Slope 0.88, Intercept 3.153, r 0.9922
Factor X: Slope 0.97, Intercept 2.995, r 0.9954
Fibrinogen-C: Slope 1.00, Intercept -8.740, r 0.9759
Protein C: Slope 1.15, Intercept -0.323, r 0.9902
Prothrombin Time (PT): Slope 0.990, Intercept 1.46, r 0.9987
PT-Based Fibrinogen: Slope 1.084, Intercept -9.93, r 0.9587
Predicate Device(s)
K002400 ACL Advance
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KQ33414
JAN 1 2 2004
Section 3 ACL TOP - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
October 24, 2003
Name of the Device:
ACL TOP
Classification Name(s):
| 81GKP
864.5400 | Instrument, Coagulation, Automated
Coagulation Instrument | Class II |
|-------------------|---------------------------------------------------------------------------------------------------------------|----------|
| 81JPA
864.5425 | System, Multipurpose for In Vitro Coagulation Studies
Multipurpose system for In Vitro Coagulation Studies | Class II |
Identification of predicate device(s):
K002400 ACL Advance
Description of the device/intended use(s):
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.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The ACL TOP is substantially equivalent in performance, intended use, safety and effectiveness to the ACL Advance (predicate device) for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.
1
Section 3 (Cont.) ACL TOP - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Precision
Within run and total precision assessed over multiple runs (n=80) using normal and abnormal levels of control plasma gave the following results:
| Reagent Type | Control Level | Mean | Within Run
%CV | Total
%CV |
|------------------------------------|----------------|-------|-------------------|--------------|
| Antithrombin
(%) | Normal | 108.5 | 5.7 | 5.8 |
| | Low Abnormal | 53.5 | 5.6 | 6.8 |
| | High Abnormal | 32.0 | 6.8 | 9.1 |
| APTT
(Seconds) | Normal | 30.3 | 1.2 | 1.6 |
| | Low Abnormal | 49.3 | 0.9 | 2.1 |
| | High Abnormal | 59.0 | 0.9 | 1.4 |
| D-Dimer
(ng/mL) | Low Control | 340 | 4.6 | 7.7 |
| | High Control | 729 | 2.5 | 4.5 |
| Factor II
(%) | Normal | 110.7 | 4.2 | 5.2 |
| | Low Abnormal | 64.5 | 4.1 | 5.3 |
| | High Abnormal | 37.5 | 3.8 | 5.6 |
| Factor V
(%) | Normal | 124.7 | 4.0 | 4.7 |
| | Low Abnormal | 79.9 | 3.0 | 4.7 |
| | High Abnormal | 43.4 | 3.6 | 4.8 |
| Factor VII
(%) | Normal | 106.2 | 3.6 | 3.9 |
| | Low Abnormal | 61.3 | 2.1 | 3.7 |
| | High Abnormal | 33.0 | 2.9 | 4.4 |
| Factor X
(%) | Normal | 114.6 | 1.8 | 2.8 |
| | Low Abnormal | 64.6 | 2.2 | 3.4 |
| | High Abnormal | 38.3 | 1.9 | 3.6 |
| Fibrinogen-C
(mg/dL) | Normal | 364.7 | 7.9 | 8.8 |
| | Low Fibrinogen | 92.9 | 7.7 | 8.4 |
| Protein C
(%) | Normal | 120.4 | 2.6 | 3.3 |
| | Low Abnormal | 30.9 | 3.0 | 4.3 |
| | High Abnormal | 18.4 | 3.7 | 4.7 |
| Prothrombin Time (PT)
(Seconds) | Normal | 11.9 | 1.3 | 1.4 |
| | Low Abnormal | 25.7 | 1.5 | 2.7 |
| | High Abnormal | 37.3 | 1.8 | 3.0 |
| PT-Based Fibrinogen
(mg/dL) | Normal | 302.6 | 3.7 | 4.1 |
| | Low Fibrinogen | 128.2 | 7.7 | 7.8 |
2
Section 3 (Cont.) ACL TOP - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of in-house performance data (Cont.):
Method Comparison
In method comparison studies evaluating citrated plasma samples, the ACL TOP and the ACL Advance (predicate device) were shown to be statistically similar as shown below.
| Reagent Type | n | Slope | Intercept | r | Sample Range |
|---|---|---|---|---|---|
| Antithrombin | |||||
| (%) | 123 | 1.03 | -1.418 | 0.9660 | 25.0 to 121.7 |
| APTT | |||||
| (Seconds) | 205 | 1.076 | -0.380 | 0.9943 | 24.2 to 236.7 |
| D-Dimer | |||||
| (ng/mL) | 120 | 1.12 | -16.0 | 0.993 | 84 to 19809 |
| Factor II | |||||
| (%) | 101 | 0.95 | -0.551 | 0.9753 | 6.0 to 128.2 |
| Factor V | |||||
| (%) | 93 | 0.81 | 4.742 | 0.9822 | 2.1 to 149.3 |
| Factor VII | |||||
| (%) | 96 | 0.88 | 3.153 | 0.9922 | 6.3 to 147.4 |
| Factor X | |||||
| (%) | 110 | 0.97 | 2.995 | 0.9954 | 5.0 to 142.3 |
| Fibrinogen-C | |||||
| (mg/dL) | 98 | 1.00 | -8.740 | 0.9759 | 121.6 to 695.0 |
| Protein C | |||||
| (%) | 123 | 1.15 | -0.323 | 0.9902 | 9.4 to 129.7 |
| Prothrombin Time (PT) | |||||
| (Seconds) | 150 | 0.990 | 1.46 | 0.9987 | 9.8 to 107.4 |
| PT-Based Fibrinogen | |||||
| (mg/dL) | 93 | 1.084 | -9.93 | 0.9587 | 121.6 to 695.0 |
3
Indications for Use Statement
510(k) Number (if known): K033414
Device Name: 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.019) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Section 2
ACL TOP Abbreviated 510(k)
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 2 2004
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
K033414 Re: Trade/Device Name: ACL TOP Regulation Number: 21 CFR 864.5400 Regulation Name: Coagulation instrument Regulatory Class: Class II Product Code: GKP Dated: October 24, 2003 Received: October 27, 2003
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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device it into of our of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may outlish 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 complics with other requirements of the Act than a Dederal statutes and regulations administered by other Federal agencies. You must or unry vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K033414
Device Name: 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033414
Prescription Use
(Per 21 CFR 801.019)
OR
Over-The-Counter Use _
Section 2
ACL TOP Abbreviated 510(k)
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