(29 days)
Not Found
No
The summary describes calibrators and control sera for in vitro diagnostic use, which are chemical reagents, not software or hardware that would typically incorporate AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
The devices are described as "multi-parametric calibrator" and "multi-parametric control sera" for in vitro diagnostic use, specifically for calibration and quality control of quantitative methods on analyzers. They are used for diagnostic purposes, not for treating or affecting the structure/function of the body.
No
Explanation: The device is described as a "multi-parametric calibrator" and "multi-parametric control sera" for in vitro diagnostic use. It is used in the "calibration" and "quality control" of quantitative methods, not to directly diagnose a disease or condition in a patient. It is a tool used within the diagnostic process, but not a diagnostic device itself.
No
The device description clearly states that the devices are lyophilized calibrators and control sera based on human serum, which are physical substances, not software.
Yes, the provided text explicitly states that the devices are for in vitro diagnostic use.
Here are the key phrases that confirm this:
- "ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use..."
- "ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use..."
- "professional use and in vitro diagnostic only."
N/A
Intended Use / 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 Pro Series Analyzers.
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 Pro Series Analyzers.
Product codes
JIX, JJY
Device Description
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 FDAapproved 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.
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
Professional use
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)
Value Assignment:
For each analyte requiring value assignment, the new lot of ELITech Clinical Systems ELICAL 2 is tested against the appropriate standard reference material on two separate ELITech Clinical Systems Selectra analyzers using the relevant ELITech Clinical Systems assay reagents. The mean analyte value is calculated and a target value is assigned on a minimum of 48 measurements taken. Verification of the value assignment is performed by calibrating with the new lot's assigned values and measuring quality control material at two levels and verifying that the values obtained are within the labeled range of the quality control.
For each analyte that requires value assignment, the new lot of ELITech Clinical Systems ELITROL I & II is tested using two separate ELITech Clinical Systems Selectra analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/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 three human profiles incorporated into its design. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 8, 2015
ELITECH GROUP C/O DEBRA HUTSON VICE PRESIDENT REGULATORY AFFAIRS/ QUALITY AFFAIRS 21720 23RD DRIVE SE, SUITE 150 BOTHELL WA 98021
Re: K151552
Trade/Device Name: ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX, JJY Dated: June 8, 2015 Received: June 9, 2015
Dear Debra Hutson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151552
Device Name
ELITech Clinical Systems ELICAL 2
Indications for Use (Describe)
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 Pro Series Analyzers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151552
Device Name
ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II
Indications for Use (Describe)
ELITech Clinical Systems 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 Pro Series Analyzers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
510(k) Summary
| 1. | Date: | July 6, 2015 |
|---|---|---|
| 2. | Submitter: | ELITech Clinical Systems SAS |
| Zone Industrielle | ||
| 61500 SEES | ||
| FRANCE | ||
| 3. | Contact Person: | Debra K. Hutson |
| VP RA/QA, EGI | ||
| 21720 23rd Dr SE, Suite 150 | ||
| Bothell, WA 98021 | ||
| Phone: 425-482-5174 | ||
| Fax: 425-482-5550 | ||
| Email: d.hutson@elitechgroup.com | ||
| 4. | ||
| 4.a | Device Description: | |
| Classification | ELITech Clinical Systems ELICAL 2 | |
| Class II | ||
| JIX | ||
| Clinical Chemistry | ||
| 21 CFR 862.1150 | ||
| 4.b | Device Description: | |
| Classification | ELITech Clinical Systems ELITROL I and ELITROL I | |
| Class I | ||
| JJY | ||
| Clinical Chemistry | ||
| 21CFR862.1660 | ||
| 5. | ||
| 5.a | Predicate Device: | K033501 |
| Roche Diagnostics | ||
| Calibrator for Diagnostics Systems (C f.a.s) | ||
| 5.b | Predicate Device: | K041127 |
| Roche Diagnostics | ||
| Precinorm U & Precipath U |
5
- 6.a
6.b
Intended Use
ELITech Clinical Systems ELICAL 2
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 Pro Series Analyzers.
Special conditions for use statement(s):
Rx ONLY
This device is intended for professional use and in vitro diagnostic only. CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Special instrument requirements:
For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM and ProS Analyzers.
Intended Use ELITech Clinical Systems ELITROL I and ELITROL II
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 Pro Series Analyzers.
Special conditions for use statement(s):
Rx ONLY
This device is intended for professional use and in vitro diagnostic only. CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Special instrument requirements:
For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM and ProS Analyzers.
Device Descriptions 7.
- ELITech Clinical Systems ELICAL 2 7.a
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 FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A
6
7.b ELITech Clinical Systems ELITROL I and ELITROL II
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.
Analyte submission history:
ELITech Clinical Systems ELICAL 2. ELITech Clinical Systems ELITROL I and ELITech Clinical Systems ELITROL II were initially cleared under K093883. Additional analytes were added to the labeling in K100263, K100525, K102993, K103376, K102647, K110780, K110830, K112029, K122083 and K122858. This submission adds values for constituents to enable the devices to be used for the calibration and control of tests for IRON FERENE (exempt) and MAGNESIUM XYLIDYL (previously cleared under K040508). The new constituents' values have been added to the labeling for ELICAL 2 and ELITROL I & II.
8. Substantial Equivalence Information
8.a Calibrator
-
- Predicate Device Name
- Calibrator for Diagnostics Systems (C f.a.s)
-
- Comparison with predicate
Similarities
| Parameter | New Device
ELITech Clinical Systems
ELICAL 2 | Predicate Device
Calibrator for Diagnostics Systems
(C f.a.s), K033501 |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 Pro Series Analyzers. | Calibrator for automated systems
(C.f.a.s.) is for use in the calibration of
quantitative Roche methods on Roche
clinical chemistry analyzers as specified
in the value sheets. |
| Format | Lyophilized calibrator based on human
serum with constituents added as
required to obtain desired components
levels | Lyophilized calibrator based on human
serum with constituents added as
required to obtain desired components
levels |
| Level | Single level | Single level |
| Handling | Carefully open the vial, avoiding the
loss of lyophilizate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation of
foam. | Carefully open one bottle, avoiding the
loss of lyophilizate, and pipette in
exactly 3 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of foam. |
7
| Parameter | New Device
ELITech Clinical Systems
ELICAL 2 | Predicate Device
Calibrator for Diagnostics Systems
(C f.a.s), K033501 |
|--------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Traceability | Traceability information is given in the
value sheet included in the box. | Traceability of the target value is given
in the respective instruction for use of
the system reagents. |
| Parameter | New Device
ELITech Clinical Systems
ELICAL 2 | Predicate Device
Calibrator for Diagnostics Systems
(C f.a.s), K033501 |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Lyophilized:
To store at 2-8°C and protected from
light until the expiry date
After reconstitution, the stabilities are :
Between 15-25 °C : 8 hours
Between 2-8 °C : 2 days
Between (-25)-(-15) °C : 4 weeks
(when frozen once)
Exceptions :
-
Stability of direct bilirubin (when
stored protected from light):
Between 15-25 °C: 3 hours
Between 2-8 °C: 8 hours
Between (-25)-(-15) °C: 2 weeks
(when frozen once) -
Stability of total bilirubin (when stored
protected from light):
Between 15-25 °C: 6 hours
Between 2-8 °C: 1 day
Between (-25)-(-15) °C: 2 weeks
(when frozen once) | Lyophilized:
Stable at 2-8°C up to expiration date.
After reconstitution, the stabilities* are :
- 8 hours at 15-25 °C.
- 2 days at 2-8 °C.
- 4 weeks at Between (-25)-(-15) °C
(when frozen once)
Exception for bilirubin total & direct
-
Stability of direct bilirubin (when stored
protected from light):
Between 15-25 °C: 3 hours
Between 2-8 °C 8 hours
Between (-25)-(-15) °C: 2 weeks (when
frozen once) -
Stability of total bilirubin (when stored protected from light):
Between 15-25 °C: 6 hours
Between 2-8 °C: 1 day
Between (-25)-(-15) °C: 2 weeks
(when frozen once) |
8.b Controls
-
- Predicate Device Name
Precinorm U & Precipath U
- Predicate Device Name
- Comparison with predicate
Similarities
| Parameter | New Device
ELITech Clinical Systems
ELITROL I & II | Predicate Device
Precinorm U & Precipath U, K041127 |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL I &
ELITROL II are multi-parametric
control sera for in vitro diagnostic use
in quality control of quantitative | For in vitro diagnostic use in quality
control by monitoring accuracy and
precision for the quantitative methods
as specified in the value sheet. |
| Parameter | New Device
ELITech Clinical Systems
ELITROL I & II | Predicate Device
Precinorm U & Precipath U, K041127 |
| | ELITech Clinical Systems methods on
ELITech Clinical Systems Selectra Pro
Series Analyzers. | |
| Format | Lyophilized human sera with
constituents added as required to
obtain desired components levels. | Lyophilized human sera with
constituents added as required to obtain
desired components levels. |
| Levels | Two levels | Two levels |
| Handling | Carefully open the vial, avoiding the
loss of lyophilizate, and pipette in
exactly 5 mL of distilled/deionized
water. Carefully close the vial and
dissolve the contents completely by
occasional gentle swirling within 30
minutes avoiding the formation
of
foam. | Carefully open the bottle, avoiding the
loss of lyophilizate, and pipette in
exactly 5 mL of distilled/deionized
water. Carefully close the bottle and
dissolve the contents completely by
occasional gentle swirling within 30
minutes. Avoid the formation of foam. |
| Stability | Lyophilized:
To store at 2-8°C and protected from
light until the expiry date
After reconstitution, the stabilities are :
Between 15-25 °C :
12 hours
Between 2-8 °C :
5 days
Between (-25)-(-15) °C : 4 weeks
(when frozen once)
Exceptions:
- Stability of direct bilirubin (when
stored protected from light):
Between 15-25 °C:
4 hours
Between 2-8 °C:
8 hours
Between (-25)-(-15) °C: 2 weeks
(when frozen once) - Stability of total bilirubin (when stored
protected from light):
Between 15-25 °C:
8 hours
Between 2-8 °C:
1 day
Between (-25)-(-15) °C: 2 weeks
(when frozen once) | Lyophilized:
Stable at 2-8°C up to expiration date.
After reconstitution, the stabilities* are : - 12 hours at 15-25 °C.
- 5 days at 2-8 °C.
- 4 weeks at (-25)-(-15) °C (when frozen
once)
*Exception for bilirubin total & direct as
noted in package insert: - Stability of direct bilirubin (when stored
protected from light):
Between 15-25 °C:
4 hours
Between 2-8 °C:
8 hours
Between (-25)-(-15) °C: 2 weeks
(when frozen once) - Stability of total bilirubin (when stored
protected from light):
Between 15-25 °C:
8 hours
Between 2-8 °C:
24 hours
Between (-25)-(-15) °C: 2 weeks
(when frozen once) |
8
9
9. Stability
ELITech Clinical Systems ELICAL 2 is purchased from a commercial vendor (previously cleared under K033501). The following is claimed for stability: ELICAL 2 is stable until the expiration date printed on the label when stored at 2-8°C prior to reconstitution. After reconstitution stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks between (-25)-(-15) C (when frozen once). The labeling states that the ELICAL 2 should be stored tightly capped and protected from light when not in use
ELITech Clinical Systems ELITROL I & II is purchased from a commercial vendor (previously cleared under K041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems ELITROL I and ELITROL II stored at 2-8°C is until the expiry date on the label. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks between (-25)-(-15)°C (when frozen once).
Exceptions:
-
Stability of direct bilirubin (when stored protected from light): Between 15-25 °C: 4 hours: Between 2-8 °C: 8 hours; Between (-25)-(-15) °C: 2 weeks (when frozen once)
-
Stability of total bilirubin (when stored protected from light): Between 15-25 °C: 8 hours; Between 2-8 °C: 1 day; Between (-25)-(-15) °C: 2 weeks (when frozen once).
10. Value Assignment
For each analyte requiring value assignment, the new lot of ELITech Clinical Systems ELICAL 2 is tested against the appropriate standard reference material on two separate ELITech Clinical Systems Selectra analyzers using the relevant ELITech Clinical Systems assay reagents. The mean analyte value is calculated and a target value is assigned on a minimum of 48 measurements taken. Verification of the value assignment is performed by calibrating with the new lot's assigned values and measuring quality control material at two levels and verifying that the values obtained are within the labeled range of the quality control.
For each analyte that requires value assignment, the new lot of ELITech Clinical Systems ELITROL I & II is tested using two separate ELITech Clinical Systems Selectra analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
11. Standard/Guidance Document Reference
No applicable mandatory performance standards or special controls exist for this device.
12. 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 devices are substantially equivalent to their respective predicate devices.