(75 days)
Not Found
No
The summary describes a calibration plasma for coagulation assays and does not mention any AI or ML components.
No.
The device is described as a calibration plasma for coagulation assays, used to calibrate laboratory systems, not to directly treat or diagnose a patient's condition.
No
Explanation: The device is a calibration plasma, which is used to calibrate coagulation assays. It does not directly diagnose any condition or disease.
No
The device is a calibration plasma, which is a biological product used for calibrating hardware coagulation analyzers. It is not software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of coagulation assays on IL and ELECTRA Coagulation Systems." Calibration materials used in laboratory tests to determine the concentration or activity of substances in patient samples are considered IVDs.
- Device Description: The description reinforces its use for calibration of coagulation assays.
- Performance Studies: The mention of precision testing and key metrics like %CV indicates it's a product used in a laboratory setting to ensure the accuracy and reliability of diagnostic tests.
- Predicate Devices: The listed predicate devices (HemosIL Assayed Reference Plasma-Normal and Assess Calibration Plasma) are also IVD products used for similar purposes in coagulation testing.
Therefore, the HemosIL Calibration plasma fits the definition of an In Vitro Diagnostic device as it is intended to be used in vitro (outside the body) to provide information for diagnostic purposes by calibrating laboratory tests.
N/A
Intended Use / Indications for Use
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
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
Not Found
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 testing was performed as part of the value assignment process by running Hemos L Calibration plasma in replicates of eight on four ACL 9000 coagulation analyzers (n=32) with the IL reagents listed below:
| Analyte | Reagent | Mean | Within Run %CV |
|---|---|---|---|
| APTT (Seconds) | HemosIL APTT-SP | 30.5 | 1.15 |
| Antithrombin (%) | HemosIL Liquid Antithrombin | 104 | 2.04 |
| Factor V (%) | HemosIL FV Deficient Plasma | 117 | 2.09 |
| Factor VIII (%) | HemosIL FVIII Deficient Plasma | 83.2 | 4.28 |
| Fibrinogen - Clauss (mg/dL) | HemosIL Fibrinogen-C | 295 | 2.30 |
| Fibrinogen - PT-Based (mg/dL) | HemosIL PT-Fib Recombinant | 288 | 5.12 |
| Plasmin Inhibitor (%) | HemosIL Plasmin Inhibitor | 97.7 | 2.02 |
| Plasminogen (%) | HemosIL Plasminogen | 84.6 | 1.59 |
| Protein C (%) | HemosIL ProClot | 96.8 | 4.73 |
| Protein S (%) | HemosIL Protein S | 70.9 | 3.39 |
| PT (Seconds) | HemosIL PT-Fib Recombinant | 11.0 | 1.45 |
| Thrombin Time (Seconds) | HemosIL Thrombin Time (2 mL) | 7.59 | 1.84 |
| HemosIL Thrombin Time (5 mL) | 16.9 | 2.13 | |
| HemosIL Thrombin Time (8 mL) | 24.5 | 1.27 | |
| von Willebrand Factor (%) | HemosIL VWF Antigen | 104 | 1.13 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See summary of performance data for Within Run %CV metrics.
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
SEP 2 8 2004
Section 3 HemosIL Calibration plasma - 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:
July 14, 2004
Name of the Device(s):
HemosIL Calibration plasma
Classification Name(s):
| 862.1150 | Calibrator | Class II |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture |
Identification of Predicate Device(s):
| K905203 | HemosIL Assayed Reference Plasma-Normal (for ELECTRA Series Analyzers) |
|---|---|
| K002400 | Assess Calibration Plasma (for ACL Family of Analyzers) |
| NOTE: FDA cleared as part of the individual ACL Coagulation Analyzers | |
| 510(k) submissions; for example, the ACL Advance (K002400). |
Description of the Device/Intended Use(s):
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Hemos L Calibration plasma is substantially equivalent in performance, intended use and safety and effectiveness to the predicate devices: Assess Calibration Plasma on the ACL Family of Coagulation Analyzers and HemosIL Assayed Reference Plasma-Normal on the ELECTRA Series of Coagulation Analyzers.
1
Section 3 (Cont.) HemosIL Calibration plasma - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Precision testing was performed as part of the value assignment process by running Hemos L Calibration plasma in replicates of eight on four ACL 9000 coagulation analyzers (n=32) with the IL reagents listed below:
| Analyte | Reagent | Mean | Within Run
%CV |
|-------------------------------|--------------------------------|------|-------------------|
| APTT (Seconds) | HemosIL APTT-SP | 30.5 | 1.15 |
| Antithrombin (%) | HemosIL Liquid Antithrombin | 104 | 2.04 |
| Factor V (%) | HemosIL FV Deficient Plasma | 117 | 2.09 |
| Factor VIII (%) | HemosIL FVIII Deficient Plasma | 83.2 | 4.28 |
| Fibrinogen - Clauss (mg/dL) | HemosIL Fibrinogen-C | 295 | 2.30 |
| Fibrinogen - PT-Based (mg/dL) | HemosIL PT-Fib Recombinant | 288 | 5.12 |
| Plasmin Inhibitor (%) | HemosIL Plasmin Inhibitor | 97.7 | 2.02 |
| Plasminogen (%) | HemosIL Plasminogen | 84.6 | 1.59 |
| Protein C (%) | HemosIL ProClot | 96.8 | 4.73 |
| Protein S (%) | HemosIL Protein S | 70.9 | 3.39 |
| PT (Seconds) | HemosIL PT-Fib Recombinant | 11.0 | 1.45 |
| Thrombin Time (Seconds) | HemosIL Thrombin Time (2 mL) | 7.59 | 1.84 |
| | HemosIL Thrombin Time (5 mL) | 16.9 | 2.13 |
| | HemosIL Thrombin Time (8 mL) | 24.5 | 1.27 |
| von Willebrand Factor (%) | HemosIL VWF Antigen | 104 | 1.13 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing strokes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 8 2004
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421
Re: K041905
Trade/Device Name: HemosIL Calibration Plasma Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: II Product Code: JIX Dated: September 17, 2004 Received: September 20, 2004
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 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). 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.
3
Page 2
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 or questions on the proce 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 Four may other 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices 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): K041905
HemosIL Calibration plasma Device Names:
Indications for Use:
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and TremosiL Canoration plasma is interest calibration plasma is prepared using citrated plasma ELECTIVE Cougarator "Dystems" to maintain the characteristics of a normal plasma pool.
र Prescription Use __ (Part 21 CFR 801 Subpart D) 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)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041905