(15 days)
Not Found
No
The device description and intended use are for calibrators and control sera, which are chemical reagents used in laboratory analyzers. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a multi-parametric calibrator and control sera for in vitro diagnostic use in the calibration and quality control of quantitative methods on analyzers, not for treating or diagnosing patients.
No
These devices are described as "calibrators" and "control sera" for in vitro diagnostic use, specifically for the calibration and quality control of other quantitative diagnostic methods. They are used to ensure the accuracy of diagnostic tests, not to perform the diagnosis themselves.
No
The device description explicitly states the device is a "lyophilized calibrator based on human serum" and "lyophilized human serum containing constituents," indicating it is a physical substance, not software.
Yes, based on the provided text, the ELITech Clinical Systems ELICAL 2, ELITROL I, and ELITROL II devices are IVDs (In Vitro Diagnostics).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states that these products are for "in vitro diagnostic use".
- Function: Calibrators and control sera are essential components used in laboratory testing to ensure the accuracy and reliability of diagnostic assays performed on patient samples. This function aligns directly with the definition of an in vitro diagnostic device.
- Predicate Devices: The listed predicate devices (Roche Diagnostics Calibrator for Automated Systems and Roche Diagnostics Precinorm U/Precipath U) are also known IVD products, further supporting the classification of the ELITech devices as IVDs.
Therefore, the text provides clear evidence that these devices are intended for use in the diagnosis of diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae, which is the definition of an IVD.
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 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 analyzers.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501), Roche Diagnostics Precinorm U/Precipath U (K041227)
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
| 510(k) Summary | |||
|---|---|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information | ||
| provides sufficient detail to understand the basis for a determination of | |||
| substantial equivalence. | APR 4 2013 | ||
| The assigned 510(k) number is: K130765 | |||
| Submitter | |||
| Address | |||
| Phone number | |||
| Fax number | ELITech Clinical Systems S.A.S. | ||
| Zone Industrielle, 61500 SEES, FRANCE |
- 33 (0)2 33 81 21 00
- 33 (0)2 33 28 77 51 | | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | |
| Date of Preparation | March 12th, 2013 | | |
| | Purpose of this submission: To obtain clearance for the devices named in this submission for use
with testing LIPASE. The devices, ELITech Clinical Systems ELICAL 2 and
ELITech Clinical Systems ELITROL I and ELITROL II, have been cleared
previously for use with testing other constituents. The LIPASE constituent
has always been present as part of the formulation of the devices; the
design and composition of the devices remains the same as it was when
cleared previously for uses with testing other analytes. All the other
previously cleared analytes remain the same for stability, value assignment
procedure, and traceability. K numbers for the previously cleared
constituents are K110830, K112029, K122858, K093883, K110780, K102993,
K122083, K112029, K100525, K100263 and K102647. | | |
| Device names:
(Proprietary names) | ELITech Clinical Systems ELICAL 2
ELITech Clinical Systems ELITROL I and ELITROL II | | |
| Predicate devices: | Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501)
Roche Diagnostics Precinorm U/Precipath U (K041227) | | |
| Device names | | | |
| 1. CALIBRATOR
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems ELICAL 2
Calibrator, multi-analyte mixture
Class II
Calibrator (21 CFR 862.1150)
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 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. | | |
:
、:
s
・・・・・
·
1
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 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 calibrator
for in vitro diagnostic use in the
calibration of quantitative ELITech
Clinical Systems methods on
ELITech Clinical Systems
Selectra Analyzers. | For in vitro diagnostic use in the
calibration of quantitative Roche
methods on Roche clinical
chemistry analysers 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. |
| 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. |
| 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) | 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) |
| | ELITech Clinical Systems Device
(ELICAL 2) | Predicate device
(Roche Calibrator f.a.s. K033501) |
| | - 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) | - 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) |
| Traceability: | ELITech Clinical Systems ELICAL 2 is traceable to values established using
a titrimetric manual method. | |
| Value Assignment: | A target value for lipase is set for the production for the new lot of ELICAL 2.
The ELITech Clinical Systems ELICAL 2 value for lipase is verified by
calibrating the test system using a previously qualified lot of ELICAL 2 and
two different approved lot of lipase reagents and then measuring the amount
of lipase in the new lot of ELICAL 2. The calibration factor of the control lots
systems must be within an acceptance range. The value obtained for lipase
must be ±9% of the target value in order for the lot to be accepted. | |
| Device name | | |
| 2. CONTROLS
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems ELITROL I and ELITROL II
Multi-analyte controls - all kinds
Class I, reserved
Quality 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 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. | |
| Intended Use | 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. | |
2
Comparison to Predicate device
| | ELITech Clinical Systems Device
(ELITROL I / ELITROL II) | Predicate Device
(Roche Precinorm U / Precipath U
K041227) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | ELITech Clinical Systems ELITROL
I and ELITROL II are multi-
parametric control sera for in vitro
diagnostic use in accuracy control | For in vitro diagnostic use in quality
control by monitoring accuracy and
precision for the quantitative methods
as specified in the value sheet. |
| | ELITech Clinical Systems Device
(ELITROL I / ELITROL II) | Predicate Device
(Roche Precinorm U / Precipath U
K041227) |
| | of quantitative ELITech Clinical
Systems methods on ELITech
Clinical Systems Selectra
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) |
3
Traceability:
ELITech Clinical Systems ELITROL I and ELITROL II are traceable to values established using a titrimetric manual method.
Value Assignment:
A target value for lipase is set for the production for the new lots of ELITROL I and ELITROL II. The ELITech Clinical Systems ELITROL I and ELITROL II values for lipase are verified by calibrating the test system using a previously qualified lot of ELICAL 2 with two different approved lots of lipase test reagents and then measuring the amount of lipase in the new lots of ELITROL i and ELITROL 11. The calibration factor of the control lots systems must be within an acceptance range. The values obtained for lipase must be ±9% of the target value in order for the lots to be accepted.
4
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.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol is a graphic representation of a person embracing a bird, which is meant to symbolize the agency's mission of protecting and promoting the health and well-being of Americans.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2013
ELITechgroup Epoch Biosciences C/O Debra K. Hutson 21720 23rd Drive. SE BOTHELL WA 98021
Re: K130765
Trade/Device Name: ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL 1 and ELITROL 2 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIX, JJY Dated: March 19, 2013 Received: March 20, 2013
Dear Ms. 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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Ms. Hutson
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -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
7
Indications for Use Form
510(k) Number (if known): K130765
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)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chester S.
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130765 510(k)
Page 1 of 2
8
Indications for Use Form
510(k) Number (if known): __k130765 Device Name:
ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II
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)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130765 510(k)
Page 2 of 2