(46 days)
HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
Values for all analytes are in the low abnormal range.
HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
The provided text describes the performance of a medical device called "HemosIL Low Abnormal Control ASSAYED," a quality control product for coagulation assays. The study aims to demonstrate that this new device is substantially equivalent to existing predicate devices.
Acceptance Criteria and Reported Device Performance:
The acceptance criteria for this device are implicitly tied to the performance of predicate devices, which are already legally marketed. The study evaluates the precision of the HemosIL Low Abnormal Control ASSAYED. The reported device performance is presented in the table below:
| Analyte | Acceptance Criteria (Implied by equivalence to predicate devices) | Reported Device Performance (Within-Run %CV) |
|---|---|---|
| Activated Partial Thromboplastin (APTT) (Seconds) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 1.84% |
| Antithrombin (% Activity) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 5.60% |
| Protein C (% Activity) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 5.96% |
| Protein S (% Activity) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 2.31% |
| Prothrombin Time (PT)* (Seconds) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 1.15% |
| Thrombin Time (Seconds) | Not explicitly stated, but expected to be comparable to or better than predicate devices | 4.00% |
Study Details:
-
Sample sizes used for the test set and the data provenance:
- Sample Sizes:
- Activated Partial Thromboplastin (APTT): n=80
- Antithrombin: n=80
- Protein C: n=80
- Protein S: n=40
- Prothrombin Time (PT): n=80
- Thrombin Time: n=80
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). The control itself is prepared from "human citrated plasma from healthy donors."
- Sample Sizes:
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study is a precision study for a quality control device, not a diagnostic device requiring expert interpretation of results. The "truth" is the expected performance of a control material.
-
Adjudication method for the test set: Not applicable. This is a precision study for a quality control, not a diagnostic study requiring adjudication.
-
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: Not applicable. This is a quality control device, not an AI-powered diagnostic tool involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The study evaluates the standalone performance of the HemosIL Low Abnormal Control as a product. There isn't an "algorithm" in the typical sense for this type of device; rather, it's about the analytical performance of the control material itself when used with "IL Coagulation and ELECTRA™ Systems."
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device is its expected value range for each analyte (i.e., its "low abnormal range") and its consistency (precision). This is established through laboratory measurement and characterization, not expert consensus, pathology, or outcomes data in the context of human diagnosis. The control is physically manufactured to simulate an abnormal sample.
-
The sample size for the training set: Not applicable. This is not a machine learning model, so there is no training set. The device is a physical quality control material.
-
How the ground truth for the training set was established: Not applicable, as there is no training set. The characteristics of the control material (mean and precision) are determined through experimental testing.
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MAY 1 4 2002
Section 3 HemosIL Low Abnormal Control - 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 Manager Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
March 28, 2002
Name of the Device(s):
HemosIL Low Abnormal Control ASSAYED
Classification Name(s):
| Common Name: | Plasma Coagulation Control |
|---|---|
| Product Code: | 81GGN |
| Regulation Number: | 21 CFR 864.5425 |
| Classification: | Class II |
Identification of Predicate Device(s):
| 510(k) No. | Predicate Device(s) | Analytes |
|---|---|---|
| K931117 | Assess™ Low Abnormal Control | Prothrombin Time (PT) |
| Activated PartialThromboplastin (APTT) | ||
| K864271 | IL Test™ Abnormal Chromogenic Control PlasmaLevel 1 | Antithrombin |
| K912711 | IL Test™ Protein C Control Plasma(component of IL Test™ ProClot kit) | Protein C |
| K930327 | IL Test™ Protein S Control Plasma(component of IL Test™ Protein S kit) | Protein S |
| K000679 | ThromboScreen Abnormal Thrombin Time Control | Thrombin Time |
Description of the Device/Intended Use(s):
HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL Low Abnormal Control is substantially equivalent to the predicate devices in performance, intended use and safety and effectiveness for the specific claimed analyte.
Section 3
HemosIL Low Abnormal Control 510(k)
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Section 3 (Cont.) HemosIL Low Abnormal Control - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
A precision study was performed with HemosIL Low Abnormal Control over multiple days with multiple runs using specific lots of reagents and control:
| Analyte | n= | Mean | Within-Run%CV |
|---|---|---|---|
| Activated Partial Thromboplastin (APTT)(Seconds) | 80 | 42.4 | 1.84 |
| Antithrombin(% Activity) | 80 | 35.4 | 5.60 |
| Protein C(% Activity) | 80 | 28.7 | 5.96 |
| Protein S(% Activity) | 40 | 40.2 | 2.31 |
| Prothrombin Time (PT)*(Seconds) | 80 | 23.5 | 1.15 |
| Thrombin Time(Seconds) | 80 | 20.0 | 4.00 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's head is facing left, and its wings are represented by curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 4 2002
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02421-3125
Re: K021022
Trade/Device Name: HemosIL Low Abnormal Control ASSAYED Regulation Number: 21 CFR § 864.5425 Regulation Name: Plasma, Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 28, 2002 Received: March 29, 2002
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 can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
621022 510(k) Number (if known):
HemosIL Low Abnormal Control ASSAYED Device Names:
Indications for Use:
HemosIL Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample.
Values for all analytes are in the low abnormal range.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K021022 |
| Prescription Use (Per 21 CFR 801.019) | OR Over-The-Counter Use |
HemosIL Low Abnormal Control 510(k)
§ 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.