(81 days)
- HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
- HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
- HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
For in vitro diagnostic use.
- The HemosIL Routine Control Level 1 is a lyophilized product prepared using human citrated plasma from healthy donors. It contains buffer, stabilizers and preservatives.
- The HemosIL Routine Control Level 2 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
- The HemosIL Routine Control Level 3 is a lyophilized product prepared using human citrated plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
The provided document describes the "HemosIL Routine Control Levels 1, 2, and 3" which are medical devices intended for quality control of coagulation assays. This is not an AI/ML powered device, therefore, many of the requested criteria such as "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (algorithm only) performance" are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" for the device, but it presents precision data as the primary performance characteristic to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the device's precision (measured by Within-Run %CV) is comparable to or better than established or acceptable values for coagulation controls.
| HemosIL Routine Control Level | Analyte | Reagent | Instrument | Mean | Reported Device Performance (Within-Run %CV) |
|---|---|---|---|---|---|
| Level 1 | Prothrombin Time (PT) | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 9000 | 9.9 seconds | 2.27 |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 11.5 seconds | 1.48 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 13.4 seconds | 1.46 | ||
| Fibrinogen | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 6000 | 270.9 mg/dL | 3.91 | |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 319.0 mg/dL | 3.13 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 283.4 mg/dL | 4.41 | ||
| Activated Partial | HemosIL APTT-SP (K973306) | ACL 9000 | 28.7 seconds | 0.98 | |
| Thromboplastin (APTT) | HemosIL SynthAFax (K955638) | ACL 6000 | 20.5 seconds | 0.91 | |
| HemosIL SynthASil (K060688) | ACL Advance | 30.1 seconds | 1.15 | ||
| Level 2 | Prothrombin Time (PT) | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 9000 | 27.2 seconds | 2.49 |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 22.6 seconds | 1.24 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 41.3 seconds | 1.56 | ||
| Activated Partial | HemosIL APTT-SP (K973306) | ACL 9000 | 47.9 seconds | 1.69 | |
| Thromboplastin (APTT) | HemosIL SynthAFax (K955638) | ACL 6000 | 40.9 seconds | 1.26 | |
| HemosIL SynthASil (K060688) | ACL Advance | 47.2 seconds | 1.26 | ||
| Level 3 | Prothrombin Time (PT) | HemosIL PT-Fibrinogen Recombinant (K981479) | ACL 9000 | 37.0 seconds | 2.65 |
| HemosIL PT-Fibrinogen (K862301) | ACL Advance | 31.4 seconds | 2.61 | ||
| HemosIL PT-Fibrinogen HS Plus (K060931) | ACL 300 | 63.5 seconds | 1.40 | ||
| Activated Partial | HemosIL APTT-SP (K973306) | ACL 9000 | 60.7 seconds | 0.62 | |
| Thromboplastin (APTT) | HemosIL SynthAFax (K955638) | ACL 6000 | 55.4 seconds | 1.98 | |
| Thromboplastin (APTT) | HemosIL SynthASil (K060688) | ACL Advance | 56.3 seconds | 1.14 |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size for Test Set: For each combination of control level, analyte, reagent, and instrument, the "Mean (n=80)" indicates that 80 measurements were performed to assess within-run precision.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Instrumentation Laboratory Co. is based in Lexington, MA, USA, it's likely the studies were conducted within the US. The nature of precision studies for quality controls usually implies prospective testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable. This device is a quality control material for laboratory tests, not a diagnostic device that requires expert interpretation of images or patient data to establish ground truth. The "truth" or target values for these controls are established through scientific measurement and statistical analysis against reference methods and materials, not expert consensus.
4. Adjudication Method for the Test Set:
- Not Applicable. As per point 3, this is not a diagnostic device involving expert interpretation or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not Applicable. This is not an AI-powered diagnostic tool, and therefore, no MRMC study comparing human readers with and without AI assistance was performed.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. This is a physical control material, not an algorithm, so standalone performance is not relevant.
7. Type of Ground Truth Used:
- The "ground truth" for the HemosIL Routine Controls is established by analytical measurement against reference methods and materials, and characterized by its mean value and precision (within-run %CV). This is a form of analytical performance data, not clinical outcomes or expert consensus. The controls are designed to mimic human plasma, and their performance is evaluated based on their stability and reproducibility on various coagulation systems.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device that requires a "training set." The product's characteristics are determined through manufacturing processes and analytical testing.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
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$\operatorname{KOf} 2 \delta \delta \neg 7$
510(k) Summary
Applicant Contact Information:
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 113 Hartwell AvenueLexington, MA 02421 |
| DEC 19 2008 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Alternate Contact: | Gabriella Erdosy, Regulatory Affairs Associate |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| Preparation Date: | November 7, 2008 |
Device Trade Names (Products Sold Separately):
HemosIL Routine Control Level 1
HemosIL Routine Control Level 2
HemosIL Routine Control Level 3
Device Regulatory Information:
| Common Name: | Plasma, Coagulation Control |
|---|---|
| Classification: | Class II |
| Product Code: | GGN |
| Regulation Number: | 21 CFR 864.5425 |
Identification of Predicate Devices:
| K021023 | HemosIL Normal Control |
|---|---|
| K021022 | HemosIL Low Abnormal Control |
| K021024 | HemosIL High Abnormal Control |
Device Descriptions:
- The HemosIL Routine Control Level 1 is a lyophilized product prepared using human citrated ● plasma from healthy donors. It contains buffer, stabilizers and preservatives.
- The HemosIL Routine Control Level 2 is a lyophilized product prepared using human citrated . plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
- The HemosIL Routine Control Level 3 is a lyophilized product prepared using human citrated . plasma from healthy donors (not heparinized plasma samples under oral anticoagulant therapy) and modified, by means of a dedicated process, to stimulate an abnormal coagulation sample. It contains buffer and stabilizers. No preservatives are included.
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Device Indications for Uses:
- . HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
- HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low . abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
- HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high . abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
Statement of Technological Characteristics of the Device Compared to Predicate Devices:
HemosIL Routine Control Levels 1, 2 and 3 are substantially equivalent to the predicate devices in performance, intended use and safety and effectiveness for the claimed analytes.
| Characteristic | New Device:HemosIL Routine Control Level 1 | Predicate Device:HemosIL Normal Control(K021023) |
|---|---|---|
| Intended Use | For the quality control ofcoagulation assays in the normalrange. | Same, except additional analytes areclaimed for the indications for use. |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |
| Characteristic | New Device:HemosIL Routine Control Level 2 | Predicate Device:HemosIL Low Abnormal Control(K021022) |
| Intended Use | For the quality control ofcoagulation assays in the lowabnormal range. | Same, except additional analytes areclaimed for the indications for use. |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |
| Characteristic | New Device:HemosIL Routine Control Level 3 | Predicate Device:HemosIL High Abnormal Control(K021024) |
| Intended Use | For the quality control ofcoagulation assays in the highabnormal range. | Same, except additional analytes areclaimed for the indications for use. |
| Matrix | Human Plasma | Same |
| Form | Lyophilized | Same |
Substantial Equivalence Comparison Table:
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Summary Performance Data:
Precision
Within run precision was assessed over multiple runs using the three levels of HemosIL Routine Control with specific lots of reagents on representative coagulation systems:
| HemosIL Routine Control Level 1 | ||||
|---|---|---|---|---|
| Analyte | Reagent | Instrument | Mean(n=80) | Within-Run%CV |
| ProthrombinTime (PT)(Seconds) | HemosILPT-FibrinogenRecombinant(K981479) | ACL 9000 | 9.9 | 2.27 |
| HemosILPT-Fibrinogen(K862301) | ACL Advance | 11.5 | 1.48 | |
| HemosILPT-FibrinogenHS Plus(K060931) | ACL 300 | 13.4 | 1.46 | |
| Fibrinogen(mg/dL) | HemosILPT-FibrinogenRecombinant(K981479) | ACL 6000 | 270.9 | 3.91 |
| HemosILPT-Fibrinogen(K862301) | ACL Advance | 319.0 | 3.13 | |
| HemosILPT-FibrinogenHS Plus(K060931) | ACL 300 | 283.4 | 4.41 | |
| Activated PartialThromboplastin(APTT)(Seconds) | HemosILAPTT-SP(K973306) | ACL 9000 | 28.7 | 0.98 |
| HemosILSynthAFax(K955638) | ACL 6000 | 20.5 | 0.91 | |
| HemosILSynthASil(K060688) | ACL Advance | 30.1 | 1.15 |
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Summary Performance Data (Cont.):
Precision
| HemosIL Routine Control Level 2 | ||||
|---|---|---|---|---|
| Analyte | Reagent | Instrument | Mean(n=80) | Within-Run%CV |
| ProthrombinTime (PT)(Seconds) | HemosILPT-FibrinogenRecombinant(K981479) | ACL 9000 | 27.2 | 2.49 |
| HemosILPT-Fibrinogen(K862301) | ACL Advance | 22.6 | 1.24 | |
| HemosILPT-FibrinogenHS Plus(K060931) | ACL 300 | 41.3 | 1.56 | |
| Activated PartialThromboplastin(APTT)(Seconds) | HemosILAPTT-SP(K973306) | ACL 9000 | 47.9 | 1.69 |
| HemosILSynthAFax(K955638) | ACL 6000 | 40.9 | 1.26 | |
| HemosILSynthASil(K060688) | ACL Advance | 47.2 | 1.26 |
:
:
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Summary Performance Data (Cont.):
Precision
| HemosIL Routine Control Level 3 | ||||
|---|---|---|---|---|
| Analyte | Reagent | Instrument | Mean(n=80) | Within-Run%CV |
| ProthrombinTime (PT)(Seconds) | HemosILPT-FibrinogenRecombinant(K981479) | ACL 9000 | 37.0 | 2.65 |
| HemosILPT-Fibrinogen(K862301) | ACL Advance | 31.4 | 2.61 | |
| HemosILPT-FibrinogenHS Plus(K060931) | ACL 300 | 63.5 | 1.40 | |
| Activated PartialThromboplastin(APTT)(Seconds) | HemosILAPTT-SP(K973306) | ACL 9000 | 60.7 | 0.62 |
| HemosILSynthAFax(K955638) | ACL 6000 | 55.4 | 1.98 | |
| HemosILSynthASil(K060688) | ACL Advance | 56.3 | 1.14 |
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Image /page/5/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 9 2008
Instrumentation Laboratory Co. C/o Carol Marble 113 Hartwell Avenue Lexington, Massachusetts 02421
Rc: K082859
Trade/Device Name: HemosIL Routine Control Level 1, 2, and 3 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GGN Dated: September 26, 2008 Received: September 29, 2008
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
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Page 2 - Ms. Marble
predicate 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Josephine Bautista
Marian Chan, PhD
Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
182859 510(k) Number (if known):
Device Name: HemosIL Routine Control Levels 1, 2 and 3
Indications for Use:
- Hemos L Routine Control Level 1 is for the quality control of coagulation assays in the . normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems.
- Hemos IL Routine Control Level 2 is for the quality control of coagulation assays in the low . abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
- . HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.
For in vitro diagnostic use.
V 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 Safe
- 510(k)
Attachment A
§ 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.