(35 days)
ACL 9000
No
The document describes a quality control material for coagulation tests and explicitly states there are no changes in fundamental scientific technology. There is no mention of AI or ML.
No
This device is for quality control of in-vitro diagnostic tests, not for directly treating a condition or providing therapy.
No
This device is described as a "quality control" for various tests, not a device that performs diagnostic testing itself. It is used to ensure the accuracy of other diagnostic devices.
No
The device description and performance studies clearly indicate this is a physical control material used in laboratory testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "For the quality control" of various chromogenic and clotting factor assays performed on IL Coagulation Systems. Quality control materials are a fundamental component of in vitro diagnostic testing, used to verify the accuracy and precision of the test system.
- Device Description: The description reinforces its use in conjunction with specific in vitro diagnostic tests (chromogenic Factor VIII and clotting factor assays).
- Performance Studies: The provided performance data includes metrics like "Within-Run %CV," which are standard measures used to evaluate the performance of quality control materials in a laboratory setting for in vitro diagnostic tests.
- Predicate Device: The mention of a predicate device (K864271 HemosIL Special Test Controls Level 1 & 2) further indicates that this device falls under the regulatory framework for IVDs, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The device is designed to be used in vitro (outside the body) to assess the performance of other in vitro diagnostic tests. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.
HemosIL Special Test Controls Level 1 & 2 is labeled:
- For the quality control in the abnormal range of the chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Factor VIII) and Free Protein S assay performed on the IL Coagulation Systems.
- For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and abnormal range (Level 2) on the IL Coagulation Systems.
- For the Quality Control of factor assays (clotting) in the abnormal range (Level 2) on the IL Coagulation Systems.
Product codes
JPA
Device Description
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Chromogenic Factor VIII:
- Reagent: ELECTRACHROME Factor VIII, Instrument: ACL 9000, Level 1: Mean (%) n=32: 67.5, Within-Run %CV: 3.30
- Reagent: ELECTRACHROME Factor VIII, Instrument: ACL 9000, Level 2: Mean (%) n=32: 37.9, Within-Run %CV: 3.53
Factor Assays (Clotting):
- Reagent: HemosIL Factor II Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 33.0, Within-Run %CV: 4.31
- Reagent: HemosIL Factor II Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 30.8, Within-Run %CV: 8.77
- Reagent: HemosIL Factor II Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 34.1, Within-Run %CV: 3.16
- Reagent: HemosIL Factor V Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 33.6, Within-Run %CV: 2.50
- Reagent: HemosIL Factor V Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 37.1, Within-Run %CV: 3.15
- Reagent: HemosIL Factor V Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 36.5, Within-Run %CV: 2.27
- Reagent: HemosIL Factor VII Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 30.5, Within-Run %CV: 3.09
- Reagent: HemosIL Factor VII Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 34.8, Within-Run %CV: 6.76
- Reagent: HemosIL Factor VII Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 33.1, Within-Run %CV: 3.53
- Reagent: HemosIL Factor VIII Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 33.7, Within-Run %CV: 5.54
- Reagent: HemosIL Factor VIII Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 36.1, Within-Run %CV: 5.52
- Reagent: HemosIL Factor VIII Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 32.4, Within-Run %CV: 6.93
- Reagent: HemosIL Factor IX Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 34.8, Within-Run %CV: 3.23
- Reagent: HemosIL Factor IX Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 34.1, Within-Run %CV: 10.07
- Reagent: HemosIL Factor IX Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 34.2, Within-Run %CV: 7.45
- Reagent: HemosIL Factor X Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 31.6, Within-Run %CV: 1.65
- Reagent: HemosIL Factor X Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 32.8, Within-Run %CV: 2.12
- Reagent: HemosIL Factor X Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 34.3, Within-Run %CV: 2.13
- Reagent: HemosIL Factor XI Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 28.5, Within-Run %CV: 2.99
- Reagent: HemosIL Factor XI Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 30.0, Within-Run %CV: 13.24
- Reagent: HemosIL Factor XI Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 30.2, Within-Run %CV: 4.34
- Reagent: HemosIL Factor XII Deficient Plasma, Instrument: ACL Classic, Mean (%) n=32: 34.1, Within-Run %CV: 7.22
- Reagent: HemosIL Factor XII Deficient Plasma, Instrument: ACL Futura/ACL Advance, Mean (%) n=32: 29.7, Within-Run %CV: 7.40
- Reagent: HemosIL Factor XII Deficient Plasma, Instrument: ACL 9000, Mean (%) n=32: 34.3, Within-Run %CV: 2.61
Key Metrics
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.
0
MAR 1 9 2004
Section 3
510(k) Summary (Summary of Safety and Effectiveness) HemosIL Special Test Controls Level 1 & 2: Expanded Indications for Use
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421
Contact Person:
Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
February 12, 2003
Name of the Device:
HemosIL Special Test Controls Level 1 & 2 (Expansion of Indications to for Use)
Classification Name:
| 864.5425 | Multipurpose System for In Vitro Coagulation Studies | Class II |
|---|---|---|
| JPA | System, Multipurpose for In Vitro Coagulation Studies |
Identification of predicate device:
K864271 HemosIL Special Test Controls Level 1 & 2
Description of the Device with Expanded Indications for Use:
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Special Test Controls Level 1 & 2 with the expanded intended use due to the new value assignments is substantially equivalent to the current legally marketed product (K864271).
Summary of Performance Data:
- Chromogenic Factor VIII: .
| Reagent | Instrument | Level | Mean (%)
n=32 | Within-Run
%CV |
|------------------------------|------------|---------|------------------|-------------------|
| ELECTRACHROME
Factor VIII | ACL 9000 | Level 1 | 67.5 | 3.30 |
| | | Level 2 | 37.9 | 3.53 |
1
Section 3 (Cont.)
510(k) Summary (Summary of Safety and Effectiveness) HemosIL Special Test Controls Level 1 & 2: Expanded Indications for Use
Summary of Performance Data (Cont.):
. Factor Assays (Clotting):
| Reagent | Instrument | Mean (%)
n=32 | Within-Run
%CV |
|---------------------|------------------------|------------------|-------------------|
| HemosIL Factor II | ACL Classic | 33.0 | 4.31 |
| | ACL Futura/ACL Advance | 30.8 | 8.77 |
| Deficient Plasma | ACL 9000 | 34.1 | 3.16 |
| HemosIL Factor V | ACL Classic | 33.6 | 2.50 |
| | ACL Futura/ACL Advance | 37.1 | 3.15 |
| Deficient Plasma | ACL 9000 | 36.5 | 2.27 |
| HemosIL Factor VII | ACL Classic | 30.5 | 3.09 |
| | ACL Futura/ACL Advance | 34.8 | 6.76 |
| Deficient Plasma | ACL 9000 | 33.1 | 3.53 |
| HemosIL Factor VIII | ACL Classic | 33.7 | 5.54 |
| | ACL Futura/ACL Advance | 36.1 | 5.52 |
| Deficient Plasma | ACL 9000 | 32.4 | 6.93 |
| HemosIL Factor IX | ACL Classic | 34.8 | 3.23 |
| | ACL Futura/ACL Advance | 34.1 | 10.07 |
| Deficient Plasma | ACL 9000 | 34.2 | 7.45 |
| HemosIL Factor X | ACL Classic | 31.6 | 1.65 |
| | ACL Futura/ACL Advance | 32.8 | 2.12 |
| Deficient Plasma | ACL 9000 | 34.3 | 2.13 |
| HemosIL Factor XI | ACL Classic | 28.5 | 2.99 |
| | ACL Futura/ACL Advance | 30.0 | 13.24 |
| Deficient Plasma | ACL 9000 | 30.2 | 4.34 |
| HemosIL Factor XII | ACL Classic | 34.1 | 7.22 |
| | ACL Futura/ACL Advance | 29.7 | 7.40 |
| Deficient Plasma | ACL 9000 | 34.3 | 2.61 |
2
Image /page/2/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.
MAR 1 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Co. 113 Hartwell Avenue Lexington, MA 02421
Re: K040359
Trade/Device Name: HemosIL Special Test Controls Level 1 & 2 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA Dated: February 12, 2004 Received: February 13, 2004
Dear Mr. 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
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,
Joseph L. Hackett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K040359
Device Name: HemosIL Special Test Controls Level 1 & 2
Indications for Use:
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the The Intended use to remests openar factor VIII tests (Levels 1 and 2) and cloting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments.
HemosIL Special Test Controls Level 1 & 2 is labeled:
- For the quality control in the abnormal range of the chromogenic tests (Antithrombin, . Plasminogen, Plasmin Inhibitor, Protein C and Factor VIII) and Free Protein S assay performed on the IL Coagulation Systems.
- For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and . abnormal range (Level 2) on the IL Coagulation Systems.
- For the Quality Control of factor assays (clotting) in the abnormal range (Level 2) on the . IL Coagulation Systems.
(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) | K040359 |
|---|---|
| -------- | --------- |
| Prescription Use | Over-The-Counter Use |
|---|---|
| (Per 21 CFR 801.019) | OR |