(29 days)
Not Found
No
The summary describes automated laboratory analyzers with modifications to existing algorithms and the automation of a previously manual function. There is no mention of AI, ML, or related concepts.
No.
The device is described as an in vitro diagnostic analyzer used for coagulation and/or fibrinolysis testing, which is for assessment and diagnosis, not treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing." This clearly indicates its function as a diagnostic tool.
No
The device description explicitly states that the ACL Elite and ACL Elite Pro are "fully automated, high-productivity analyzers," which are physical hardware devices used for in vitro diagnostic testing. The modifications mentioned are to the analytical capabilities of these hardware systems.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the ACL Elite and ACL Elite Pro are "designed specifically for in vitro diagnostic clinical use".
N/A
Intended Use / Indications for Use
The ACL Elite and ACL Elite Pro are fully automated, high-productivity analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
Product codes
JPA
Device Description
The ACL Elite and ACL Elite Pro are fully automated, high-productivity analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
The analytical modifications to the ACL 8000/9000/10000 introduced with the new family members (ACL Elite and ACL Elite Pro) include the following:
- Modification to the test parameter (revised use of the Secondary Algorithm) for several . PT and APTT assays.
- Addition of dedicated calibration for HemosIL Factor VIII and HemosIL Factor IX . Deficient Plasmas, when used in conjunction with HemosIL APTT-SP.
- Introduction of automated factor parallelism, which is a manual function on the ACL . 8000/9000/10000.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Within run and total precision assessed over multiple runs on the ACL Elite Pro using three levels of control plasma for factors deficient plasmas, APTT and PT, and two levels of control plasmas for fibrinogen.
- HemosIL Factor VIII (K034007) w/ APTT-SP: Normal Control (n=50, Mean=85.3, Within Run % CV=4.1, Total %CV=4.5), Special Test Control Level 1 (n=50, Mean=72.4, Within Run % CV=2.9, Total %CV=3.6), Special Test Control Level 2 (n=50, Mean=36.3, Within Run % CV=4.6, Total %CV=5.4).
- HemosIL Factor IX (K031829) w/ APTT-SP: Normal Control (n=50, Mean=115.6, Within Run % CV=2.7, Total %CV=5.2), Special Test Control Level 1 (n=50, Mean=76.2, Within Run % CV=2.3, Total %CV=4.5), Special Test Control Level 2 (n=50, Mean=41.0, Within Run % CV=3.3, Total %CV=5.1).
- HemosIL APTT-SP (K973306): Normal Control (n=50, Mean=29.3, Within Run % CV=1.1, Total %CV=2.0), Low Abnormal Control (n=50, Mean=46.1, Within Run % CV=1.9, Total %CV=4.1), High Abnormal Control (n=50, Mean=56.9, Within Run % CV=2.2, Total %CV=4.7).
- HemosIL SynthASil (K953981): Normal Control (n=50, Mean=29.0, Within Run % CV=0.8, Total %CV=1.8), Low Abnormal Control (n=50, Mean=51.9, Within Run % CV=1.0, Total %CV=1.5), High Abnormal Control (n=50, Mean=60.5, Within Run % CV=1.2, Total %CV=1.2).
- HemosIL PT-Fibrinogen (K862301): PT-Fibrinogen Prothrombin Time (Seconds): Normal Control (n=50, Mean=12.3, Within Run % CV=0.6, Total % CV=1.1), Low Abnormal Control (n=50, Mean=20.7, Within Run % CV=0.9, Total % CV=1.1), High Abnormal Control (n=50, Mean=25.5, Within Run % CV=0.8, Total % CV=1.4). Fibrinogen (mg/dL): Normal Control (n=50, Mean=277.9, Within Run % CV=4.4, Total % CV=4.6), Low Fibrinogen Control (n=50, Mean=132.9, Within Run % CV=3.6, Total % CV=5.5).
- HemosIL PT-Fibrinogen Recombinant (K981479): Prothrombin Time (Seconds): Normal Control (n=50, Mean=10.7, Within Run % CV=1.0), Low Abnormal Control (n=50, Mean=35.0, Within Run % CV=1.1, Total % CV=3.4), High Abnormal Control (n=50, Mean=51.6, Within Run % CV=1.4, Total % CV=3.4). Fibrinogen (mg/dL): Normal Control (n=50, Mean=297.6, Within Run % CV=3.8, Total % CV=6.7), Low Fibrinogen Control (n=50, Mean=113.1, Within Run % CV=5.3, Total % CV=6.4).
Method Comparison:
Comparison studies evaluating citrated plasma samples, the ACL Elite/ACL Elite Pro versus the ACL 9000 (predicate device) was shown to be statistically similar for the tests listed.
- HemosIL Factor VIII: FVIII w/ APTT-SP (% Act.), n=47, Slope=0.909, r=0.9938.
- HemosIL Factor IX: FIX with APTT-SP (% Act.), n=49, Slope=0.948, r=0.9914.
- HemosIL APTT-SP: APTT (Seconds), n=54, Slope=1.032, r=0.9990.
- HemosIL SynthASil: APTT (Seconds), n=52, Slope=1.009, r=0.9981.
- HemosIL PT-Fibrinogen: PT (sec), n=49, Slope=0.989, r=0.9985; Fibrinogen (mg/dL), n=47, Slope=0.996, r=0.9848.
- HemosIL PT-Fibrinogen Recombinant: PT (sec), n=49, Slope=0.972, r=0.9993; Fibrinogen (mg/dL), n=47, Slope=0.974, r=0.9992.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Section 3 ACL Elite and ACL Elite Pro 510(k) Summary
K060/62
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director 781-861-4467 Phone: 781-861-4207 Fax:
Summary Prepared:
January 20, 2006
Device Name:
ACL Elite and ACL Elite Pro
Classification Name:
Multipurpose system for in vitro coagulation studies (864.5425) Regulation Section: Classification: Class II JPA Product Code: Hematology Panel:
Legally Marketed Device:
ACL 9000 (ACL 8000 and ACL 10000) K000053
Device Description:
The ACL Elite and ACL Elite Pro are fully automated, high-productivity analyzers 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 systems provide results for both direct hemostasis measurements and calculated parameters.
The analytical modifications to the ACL 8000/9000/10000 introduced with the new family members (ACL Elite and ACL Elite Pro) include the following:
- Modification to the test parameter (revised use of the Secondary Algorithm) for several . PT and APTT assays.
- Addition of dedicated calibration for HemosIL Factor VIII and HemosIL Factor IX . Deficient Plasmas, when used in conjunction with HemosIL APTT-SP.
- Introduction of automated factor parallelism, which is a manual function on the ACL . 8000/9000/10000.
1
Section 3 (Cont.) ACL Elite and ACL Elite Pro 510(k) Summary
Statement of Technological Characteristics of the Device Compared to Predicate Device:
The indications for use/intended use, operating principle and performance claims of the ACL Elite and ACL Elite Pro are substantially equivalent to the legally marketed device, the ACL 8000/9000/10000 (K000053).
Summary of Performance Data:
Precision
Within run and total precision assessed over multiple runs on the ACL Elite Pro using three levels of control plasma for factors deficient plasmas, APTT and PT, and two levels of control plasmas for fibrinogen gave the following results:
| Test | FVIII (% Activity) | ||||
|---|---|---|---|---|---|
| HemosIL | |||||
| Factor VIII | |||||
| (K034007) | |||||
| w/ APTT-SP | Material | n | Mean | Within Run | |
| % CV | Total | ||||
| %CV | |||||
| Normal Control | 50 | 85.3 | 4.1 | 4.5 | |
| Special Test Control Level 1 | 50 | 72.4 | 2.9 | 3.6 | |
| Special Test Control Level 2 | 50 | 36.3 | 4.6 | 5.4 | |
| FIX (% Activity) | |||||
| HemosIL | |||||
| Factor IX | |||||
| (K031829) | |||||
| w/ APTT-SP | Material | n | Mean | Within Run | |
| % CV | Total | ||||
| %CV | |||||
| Normal Control | 50 | 115.6 | 2.7 | 5.2 | |
| Special Test Control Level 1 | 50 | 76.2 | 2.3 | 4.5 | |
| Special Test Control Level 2 | 50 | 41.0 | 3.3 | 5.1 | |
| APTT (Seconds) | |||||
| HemosIL | |||||
| APTT-SP | |||||
| (K973306) | Material | n | Mean | Within Run | |
| % CV | Total | ||||
| %CV | |||||
| Normal Control | 50 | 29.3 | 1.1 | 2.0 | |
| Low Abnormal Control | 50 | 46.1 | 1.9 | 4.1 | |
| High Abnormal Control | 50 | 56.9 | 2.2 | 4.7 | |
| APTT (Seconds) | |||||
| HemosIL | |||||
| SynthASil | |||||
| (K953981) | Material | n | Mean | Within Run | |
| % CV | Total | ||||
| %CV | |||||
| Normal Control | 50 | 29.0 | 0.8 | 1.8 | |
| Low Abnormal Control | 50 | 51.9 | 1.0 | 1.5 | |
| High Abnormal Control | 50 | 60.5 | 1.2 | 1.2 |
2
Section 3 (Cont.) ACL Elite and ACL Elite Pro 510(k) Summary
Summary of Performance Data (Cont.):
Precision (Cont.)
| Test | Prothrombin Time (Seconds) | ||||
|---|---|---|---|---|---|
| Material | n | Mean | Within Run | ||
| % CV | Total | ||||
| % CV | |||||
| HemosIL | |||||
| PT-Fibrinogen | |||||
| (K862301) | Normal Control | 50 | 12.3 | 0.6 | 1.1 |
| Low Abnormal Control | 50 | 20.7 | 0.9 | 1.1 | |
| High Abnormal Control | 50 | 25.5 | 0.8 | 1.4 | |
| Fibrinogen (mg/dL) | |||||
| Material | n | Mean | Within Run | ||
| % CV | Total | ||||
| % CV | |||||
| Normal Control | 50 | 277.9 | 4.4 | 4.6 | |
| Low Fibrinogen Control | 50 | 132.9 | 3.6 | 5.5 | |
| HemosIL | |||||
| PT-Fibrinogen | |||||
| Recombinant | |||||
| (K981479) | Prothrombin Time (Seconds) | ||||
| Material | n | Mean | Within Run | ||
| % CV | |||||
| Normal Control | 50 | 10.7 | 1.0 | ||
| Low Abnormal Control | 50 | 35.0 | 1.1 | ||
| High Abnormal Control | 50 | 51.6 | 1.4 | 3.4 | |
| Fibrinogen (mg/dL) | |||||
| Material | n | Mean | Within Run | ||
| % CV | |||||
| Normal Control | 50 | 297.6 | 3.8 | 6.7 | |
| Low Fibrinogen Control | 50 | 113.1 | 5.3 | 6.4 |
Method Comparison
In comparison studies evaluating citrated plasma samples, the ACL Elite/ACL Elite Pro versus the ACL 9000 (predicate device) was shown to be statistically similar for the tests listed below:
| Test | Parameter | n | Slope | r |
|---|---|---|---|---|
| HemosIL Factor VIII | FVIII w/ APTT-SP (% Act.) | 47 | 0.909 | 0.9938 |
| HemosIL Factor IX | FIX with APTT-SP (% Act.) | 49 | 0.948 | 0.9914 |
| HemosIL APTT-SP | APTT (Seconds) | 54 | 1.032 | 0.9990 |
| HemosIL SynthASil | APTT (Seconds) | 52 | 1.009 | 0.9981 |
| HemosIL | PT (sec) | 49 | 0.989 | 0.9985 |
| PT-Fibrinogen | Fibrinogen (mg/dL) | 47 | 0.996 | 0.9848 |
| HemosIL | PT (sec) | 49 | 0.972 | 0.9993 |
| PT-Fibrinogen Recombinant | Fibrinogen (mg/dL) | 47 | 0.974 | 0.9992 |
Special 510(k): ACL Elite and ACL Elite Pro
Page 3 of 3
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of Americans. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
FEB 2 1 2006
K060162 Re: Trade/Device Name: ACL Elite and ACL Elite Pro Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: JPA Dated: January 20, 2006 Received: January 23, 2006
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 for associated in the 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 r ou mayy atteres, 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 n may or babyer to back 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 r reaso o a recer 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); 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
4
Page 2 -
If you desire specific information about the application of labeling requirements to your device, If you destre specific infortion and advertising of your device, please contact the Office of In of quotions on all process Evaluation and Safety at (240) 276-0484. Also, please note the vitro Diagnoutied, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may oouall other generational 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/industry/support/index.html
Sincerely yours,
lobetz Beckerh
Robert L. Becker, Jr., MD, PK.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K060162
Device Name: ACL Elite and ACL Elite Pro
Indications for Use:
The ACL Elite and ACL Elite Pro are fully automated, high-productivity analyzers 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 systems provide 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 807 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)
Jazhine Bautista
Division Sign-off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060162
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