(35 days)
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.
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.
The provided text describes the 510(k) summary for the HemosIL Special Test Controls Level 1 & 2, focusing on the expanded indications for use for chromogenic Factor VIII tests and clotting factor assays. It details the performance data that supports the substantial equivalence of the device.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a separate, defined threshold. Instead, it presents the "reported device performance" in terms of "Mean (%)" and "Within-Run %CV" for various assays. The implication is that these reported values are deemed acceptable for the expanded indications, as the device received 510(k) clearance, signifying substantial equivalence to a legally marketed predicate device.
| Reagent (Expanded Indication) | Instrument | Level | Reported Mean (%) (n=32) | Reported Within-Run %CV | Acceptance Criteria (Implied) |
|---|---|---|---|---|---|
| ELECTRACHROME Factor VIII | ACL 9000 | Level 1 | 67.5 | 3.30 | Not explicitly stated |
| ELECTRACHROME Factor VIII | ACL 9000 | Level 2 | 37.9 | 3.53 | Not explicitly stated |
| HemosIL Factor II | ACL Classic | 33.0 | 4.31 | Not explicitly stated | |
| HemosIL Factor II | ACL Futura/ACL Advance | 30.8 | 8.77 | Not explicitly stated | |
| Deficient Plasma (Factor II) | ACL 9000 | 34.1 | 3.16 | Not explicitly stated | |
| HemosIL Factor V | ACL Classic | 33.6 | 2.50 | Not explicitly stated | |
| HemosIL Factor V | ACL Futura/ACL Advance | 37.1 | 3.15 | Not explicitly stated | |
| Deficient Plasma (Factor V) | ACL 9000 | 36.5 | 2.27 | Not explicitly stated | |
| HemosIL Factor VII | ACL Classic | 30.5 | 3.09 | Not explicitly stated | |
| HemosIL Factor VII | ACL Futura/ACL Advance | 34.8 | 6.76 | Not explicitly stated | |
| Deficient Plasma (Factor VII) | ACL 9000 | 33.1 | 3.53 | Not explicitly stated | |
| HemosIL Factor VIII | ACL Classic | 33.7 | 5.54 | Not explicitly stated | |
| HemosIL Factor VIII | ACL Futura/ACL Advance | 36.1 | 5.52 | Not explicitly stated | |
| Deficient Plasma (Factor VIII) | ACL 9000 | 32.4 | 6.93 | Not explicitly stated | |
| HemosIL Factor IX | ACL Classic | 34.8 | 3.23 | Not explicitly stated | |
| HemosIL Factor IX | ACL Futura/ACL Advance | 34.1 | 10.07 | Not explicitly stated | |
| Deficient Plasma (Factor IX) | ACL 9000 | 34.2 | 7.45 | Not explicitly stated | |
| HemosIL Factor X | ACL Classic | 31.6 | 1.65 | Not explicitly stated | |
| HemosIL Factor X | ACL Futura/ACL Advance | 32.8 | 2.12 | Not explicitly stated | |
| Deficient Plasma (Factor X) | ACL 9000 | 34.3 | 2.13 | Not explicitly stated | |
| HemosIL Factor XI | ACL Classic | 28.5 | 2.99 | Not explicitly stated | |
| HemosIL Factor XI | ACL Futura/ACL Advance | 30.0 | 13.24 | Not explicitly stated | |
| Deficient Plasma (Factor XI) | ACL 9000 | 30.2 | 4.34 | Not explicitly stated | |
| HemosIL Factor XII | ACL Classic | 34.1 | 7.22 | Not explicitly stated | |
| HemosIL Factor XII | ACL Futura/ACL Advance | 29.7 | 7.40 | Not explicitly stated | |
| Deficient Plasma (Factor XII) | ACL 9000 | 34.3 | 2.61 | Not explicitly stated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: The "n=32" is explicitly stated for the "Mean (%)" in the performance tables, indicating 32 measurements were taken for each reported value.
- Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The study involves quality control materials for in vitro coagulation studies, where "ground truth" would typically refer to the target or reference values established for the control material itself, rather than expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The study focuses on the analytical performance (mean and precision) of the control material on specific instruments, not on the interpretation of results by multiple human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not performed, nor is it relevant to this type of device (in vitro diagnostic quality control material). This device is a control material for laboratory tests, not an AI-powered diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device. The "device" itself is a control material, not an algorithm. The performance data presented is the "standalone" performance of the control material when assayed on various laboratory instruments.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for quality control materials refers to the assigned or target values for the analytes within the control. This is typically established through rigorous analytical methods, often characterized through inter-laboratory studies or traceability to reference materials. The document states that the intended use is being expanded with the addition of "value assignments," implying such a characterization was performed, but the specific type of "ground truth" establishment (e.g., a specific reference method or consensus process) is not detailed here.
8. The sample size for the training set
This is not applicable as the device is a quality control material and not an algorithm requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as the device does not involve a training set.
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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 |
|---|---|---|---|---|
| ELECTRACHROMEFactor VIII | ACL 9000 | Level 1 | 67.5 | 3.30 |
| Level 2 | 37.9 | 3.53 |
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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 |
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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
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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 |
§ 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.