(46 days)
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes two in vitro diagnostic devices, ELICAL 2 (a calibrator) and ELITROL I / ELITROL II (controls), and their comparison to predicate devices for 510(k) clearance.
However, the documentation provided does not contain information related to an AI/ML-based device. It describes traditional in vitro diagnostic devices, specifically a multi-analyte calibrator and multi-analyte controls based on human serum.
Therefore, I cannot provide an answer that includes details typical of an AI/ML device study, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or a table of acceptance criteria and reported device performance for an AI/ML model.
The document focuses on demonstrating substantial equivalence of the new calibrator and control devices to existing predicate devices based on attributes like intended use, format, levels, handling, traceability, and stability. The "performance data" mentioned in the Conclusion likely refers to the analytical performance characteristics (e.g., stability) that were tested to show the new devices perform comparably to the predicates, rather than the performance of an AI algorithm.
To answer your request thoroughly, I need information about an AI/ML device study. The current document does not provide the necessary details.
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SECTION 8 - 510(k) Summary
AUG 3 0 2011
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination of sub-stantial equivalence. |
|---|---|
| The assigned 510(k) number is: K112029 | |
| Submitter | SEPPIM S.A.S. |
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | July 14, 2011 |
| Device names | |
| CALIBRATOR | |
| Trade/proprietary Name: | ELITech Clinical Systems ELICAL 2 |
| Common or Usual Name: | Calibrator, multi-analyte mixture, "ELICAL 2" |
| Device Class | Class II |
| Classification name | Calibrator (21 CFR 862.1150) |
| Product code | JIX- Calibrator, multi-analyte mixture |
| Predicate device | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501) |
| Device description | ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIV ac-cording to FDA-approved methods or methods in compliance with the Euro-pean Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitrodiagnostic use in the calibration of quantitative ELITech Clinical Systemsmethods on ELITech Clinical Systems Selectra Analyzers |
Comparison to Predicate device
| ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s. K033501) | |
|---|---|---|
| Intended use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibratorfor in vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods onELITech Clinical Systems Selec-tra Analyzers. | For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinical chemis-try analysers as specified in thevalue sheets. |
| Format | Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels | Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels |
| ELITech Clinical Systems Device(ELICAL 2) | Predicate device(Roche Calibrator f.a.s. K033501) | |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam. | Carefully open one bottle, avoidingthe loss of lyophilizate, and pipettein exactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam. |
| Traceability | Traceability information is given inthe value sheet included in the box. | Traceability of the target value isgiven in the respective instructionfor use of the system reagents. |
| Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry date | Lyophilized:Stable at 2-8°C up to expirationdate. |
| After reconstitution, the stabilitiesare : | After reconstitution, the stabilities*are : | |
| Between 15-25 °C:8 hours | - 8 hours at 15-25 °C. | |
| Between 2-8 °C:2 daysBetween (-25)-(-15) °C: 4 weeks(when frozen once) | - 2 days at 2-8 °C.- 4 weeks at Between (-25)-(-15) °C(when frozen once) | |
| Exceptions :- Stability of direct bilirubin (whenstored protected from light): | Exception for bilirubin total & direct- Stability of direct bilirubin (whenstored protected from light): | |
| Between 15-25 °C:3 hours | Between 15-25 °C:3 hours | |
| Between 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (whenstored protected from light): | Between 2-8 °C8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once)- Stability of total bilirubin (whenstored protected from light): | |
| Between 15-25 °C:6 hours | Between 15-25 °C:6 hours | |
| Between 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once) | Between 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once) |
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| Device name | |
|---|---|
| CONTROLSTrade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code | ELITech Clinical Systems ELITROL I and ELITROL IIMulti-analyte controls - all kinds, "ELITROL I"- "ELITROL II"Class IQuality control material (assayed and unassayed). (21 CFR 862.1660)JJY- Multi-analyte controls - all kinds |
| Predicate device | Roche Diagnostics Precinorm U (K041227)Roche Diagnostics Precipath U (K041227) |
| Device description | ELITech Clinical Systems ELITROL I and ELITROL II are two level qualitycontrol products consisting of lyophilized human serum containing constitu-ents at desired levels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A. |
| Intended Use | ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametriccontrol sera for in vitro diagnostic use in quality control of quantitative ELITechClinical Systems methods on ELITech Clinical Systems Selectra Analyzers. |
Comparison to Predicate device
| ELITech Clinical Systems Device(ELITROL I / ELITROL II) | Predicate Device(Roche Precinorm U / Precipath UK041227) | |
|---|---|---|
| Intended use | ELITech Clinical Systems ELITROLI and ELITROL II are multi-parametric control sera for in vitrodiagnostic use in accuracy controlof quantitative ELITech ClinicalSystems methods on ELITech Clin-ical Systems Selectra Analyzers. | For in vitro diagnostic use in qualitycontrol by monitoring accuracy andprecision for the quantitative meth-ods as specified in the value sheet |
| Format | Lyophilized human sera with con-stituents added as required to ob-tain desired components levels | Lyophilized human sera with con-stituents added as required to ob-tain desired components levels |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding theloss of lyophilizate, and pipette inexactly 5 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam. | Carefully open the bottle, avoidingthe loss of lyophilizate, and pipettein exactly 5 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam. |
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| ELITech Clinical Systems Device(ELITROL I / ELITROL II) | Predicate Device(Roche Precinorm U / Precipath UK041227) | |
|---|---|---|
| Stability | Lyophilized:To store at 2-8°C and protectedfrom light until the expiry date | Lyophilized:Stable at 2-8°C up to expirationdate. |
| After reconstitution, the stabilitiesare :Between 15-25 °C :12 hoursBetween 2-8 °C :5 daysBetween (-25)-(-15) °C : 4 weeks(when frozen once) | After reconstitution, the stabilities*are :- 12 hours at 15-25 °C.- 5 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once) | |
| Exceptions:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once) | *Exception for bilirubin total & directas noted in package insert:- Stability of direct bilirubin (whenstored protected from light):Between 15-25 °C:4 hoursBetween 2-8 °C:8 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once) | |
| - Stability of total bilirubin (whenstored protected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:1 dayBetween (-25)-(-15) °C: 2 weeks(when frozen once) | - Stability of total bilirubin (whenstored protected from light):Between 15-25 °C:8 hoursBetween 2-8 °C:24 hoursBetween (-25)-(-15) °C: 2 weeks(when frozen once) |
Conclusion
The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that they met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
ELITechGroup SEPPIM S.A.S. Epoch Biosciences c/o Ms. Debra K. Hutson 21720 23 rd Dr SE Suite 150 Bothell, Washington 98021
AUG 300 2011
Re: K112029
Trade Name: ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I /II Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX, JJY Dated: July 14, 2011 Received: July 15, 2011
Dear Ms. Hutson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is desires marketed in intersta for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrossile) to regally manage province and one of the Enderal Food. Drug commerce prior to May 20, 1970, the chacinent with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with as personal application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, subject to the gentration, listing of the arguint misting and general controls provisions of the received requirementibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (see adove) into online sits). The subjecting your device
it may be subject to such additional controls. Existing marts 800 to 805. In additio it may be subject to such additional controllar controllers (CFR), Parts 800 to 895. In addition, FDA
can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 can be found in Thic 21, Code of I occrain concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issuality of a subscribe with other requirements of the Act
that FDA has made a determination that your device of the requirements of the Act that FDA nas made a decirimation in and regulations administered by other Federal agencies. You must or any Federal statutes and regulations dominations on registration and listing (21
comply with all the Act's requirements, including, assocting (reporting (reporting of comply with all the Act 3 requirements 801 and 809); medical device reporting of
CFR Part 807); labeling (21 CFR Parts (11 and 800); and monufacturing practice CFR Part 807); labeling (21 CFR 803); and good manufacturing practice medical device-iclated adverse ovelity systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
G.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K112029
ELITech Clinical Systems ELICAL 2 Device Name: _
Indications for Use:
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112029
Page 1 of
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Indications for Use Form
510(k) Number (if known): K 11 JD2
ELITech Clinical Systems ELITROL I & ELITROL II Device Name:
Indications for Use:
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k< 11 2029
Page 1 of
§ 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.