(32 days)
Not Found
No
The device is a calibrator, a chemical reagent used to establish a calibration curve for an assay. The description focuses on its composition, stability, and performance in a laboratory setting, with no mention of AI or ML.
No
The device is an in vitro diagnostic product used for preparing a calibration curve for a kinetic determination of angiotensing enzyme (ACE) assay, not for treating a condition.
No
This device is described as a "Calibrator" used to prepare a calibration curve for an assay, not perform the assay itself. It aids in the diagnostic process but is not a standalone diagnostic tool.
No
The device description clearly states it is a lyophilized preparation of human serum containing enzymes, preservatives, and stabilizers, provided in vials. This is a physical, chemical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "The product is for in vitro diagnostic use only."
Furthermore, the device description and intended use clearly indicate that it is used in a laboratory setting to calibrate an assay for measuring a substance (angiotensin converting enzyme) in human serum or plasma, which are biological samples. This aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ACE Calibrator is a device intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensing enzyme (ACE) assay in human serum or plasma. The product is for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The ACE Calibrator is a single level, single analyte serum based calibrator. It consists of a lyophilized preparation of human serum containing angiotensin converting enzyme (porcine source), in a buffered human serum base with added preservatives and stabilizers.
The kit consists of six vials, containing 1 mL per vial. Once reconstituted, the calibrator is stable for 7 days when stored capped at 2-8°C.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
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)
(1) Traceability
The Sentinel ACE Calibrator was value assigned using an in-house protocol whereby proficiency survey material from the College of American Pathologists (CAP) ACE program, which has assigned values for the Trinity ACE readent system, was used to assign a value to the Sentinel master calibrator. The value assignment involved running at least two runs per day over two days on two Abbott Architect analyzers using Sentinel ACE Liquid assay. Five replicates of pooled ACE calibrator were analyzed on each run to give a total of 20 replicates. The assigned value was the mean of the 20 replicates.
The assigned value was then verified by running commercially available control sera for ACE as well as available ACE proficiency survey material from CAP and WEQAS (Wales External Quality Assurance Scheme).
Defined acceptance criteria was met for the value assignment and verification process.
No internationally recognised certified reference material or method is available for the measurement of ACE. As such the Sentinel ACE Calibrator targeted traceability to the Trinity Biotech ACE reagent system, which is considered to be a market leader in the determination of Angiotensin Converting Enzyme activity.
(2) Stability
(i) Shelf-life Stability
Real time stability data was presented on 2 different batches of ACE Calibrator. Accelerated heat stress testing was not performed on the calibrator as the angiotensin converting enzyme in the calibrator is heat labile and therefore not stable at elevated temperatures.
At time of manufacture, calibrator was reconstituted with 1 mL of deionised water and tested on a Cobas Mira, using Trinity Biotech ACE reagent. The calibrator recovery value represented the initial time result.
After 46 months (batch # 1) and 38 months (batch # 2) storage at 2-8°C as a lyophilized and capped fill, the Calibrator was re-tested after being reconstituted with deionised water and stored for 7 days at 2-8°C. The calibrator mean recovery result after 46 and 38 months respectively was compared against the initial time result (at time of manufacture) and % bias versus initial time result calculated.
The data demonstrates that the un-reconstituted calibrator when stored sealed at 2-8°C is stable for at least 38 months. Based on the shelf life data presented, the claimed shelf will be 36 months (3 years) from date of manufacture, which is the same shelf life as claimed by the predicate device.
(ii) Reconstituted Stability (Open vial)
3 vials of ACE Calibrator were reconstituted with 1 mL of deionised water as instructed on the package insert and pooled into a single vial. The pooled calibrator was then stored at 2-8°C for at least 7 days.
ACE Calibrator reconstituted for 7 days at 2-8℃ was tested against freshly reconstituted ACE calibrator. Sentinel ACE Liquid assay was used for testing together with approved instrument application on the Abbott Architect analyzer. Freshly reconstituted calibrator was used to calibrate the ACE assay. ACS ACE Controls were run as Quality Control material. The calibrator and controls were run in triplicate.
In addition to 7 days, calibrator was also tested at day 2 and day 8 (stored at 2-8°C).
The recovery of the freshly reconstituted calibrator was compared to the recovery of calibrator stored for 7 days refrigerated at 2-8°C.
The results demonstrated that the ACE Calibrator met the acceptance criteria of within ± 5.0% difference in ACE recoveries between fresh calibrator and calibrator reconstituted and stored for 7 days at 2-8°C.
The reconstituted ACE Calibrator is stable and can be used for up to 7 days when stored capped and refrigerated at 2-8°C.
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.
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
Page 1 of 5
510(k) SUMMARY
JUL 28 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is: K141728.
510(k) holder/Submitter:
Sentinel CH. SpA
Submitter's Address:
Via Robert Koch, 2 20152 Milano — ITALY
Submitter's Telephone: Submitter's Fax:
+39 023455141 +39 0234551464
| Contact Name: | Patricia Dupé |
|---|---|
| Contact Email: | patriciadupe@sentinel.it |
| Contact Title: | Regulatory Affairs Manager |
| Contact Telephone: | +39 0234551496 |
510(k) Summary Preparation Date:
17th July 2014
| Proprietary Name: | ACE Calibrator |
|---|---|
| Common or Usual Name: | Angiotensin Converting Enzyme Calibrator |
| Classification: | Calibrator, Secondary (21 CFR 862.1150) |
| Class II | |
| Clinical Chemistry | |
| JIT | |
| Predicate Device: | Analytical Control Systems ACE Calibrator |
| Product Code, SC-131 | |
| Cleared under 510(k) - K930477 |
1
Page 2 of 5
Description of the Device:
The ACE Calibrator is a single level, single analyte serum based calibrator. It consists of a lyophilized preparation of human serum containing angiotensin converting enzyme (porcine source), in a buffered human serum base with added preservatives and stabilizers.
The kit consists of six vials, containing 1 mL per vial. Once reconstituted, the calibrator is stable for 7 days when stored capped at 2-8°C.
Statement of the Intended Use:
ACE Calibrator is intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. The product is for in-vitro diagnostic use only.
Summary of the technological characteristics of the device compared to the predicate device:
The Sentinel ACE Calibrator is substantially equivalent to Analytical Control Systems (ACS) ACE Calibrator.
Table 1 summarizes the technological characteristics of the ACE Calibrator, illustrating the similarities and differences between the Sentinel ACE Calibrator and Analytical Control Systems ACE Calibrator (Predicate Device).
2
동물에게서부분들
| able
1
T
1
- | |
|--------------------------|--|
|--------------------------|--|
| Characteristic | Sentinel ACE Calibrator | ACS ACE Calibrator
(Predicate) |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Intended to be used with
the Sentinel ACE Liquid
Reagent for the preparation of
the calibration curve for the
kinetic determination of
angiotensin converting enzyme
(ACE) assay in human serum or
plasma. | Intended to be used to prepare a
reference curve for the kinetic
determination of
angiotensin
converting enzyme
(ACE)
in
human serum or plasma. |
| Format/Matrix | Lyophilized preparation of human
serum containing ACE (porcine),
preservatives and stabilisers. | Lyophilized preparation of human
serum containing ACE (porcine),
preservatives and stabilisers. |
| Preparation | Carefully peel the metal flip seal
from the vial using tweezers or a
spatula to assist. | Add 1.0mL water to vial of ACE
Calibrator. Swirl gently, allowing to
stand for 5 minutes. Invert gently |
| | Gently remove the stopper to
avoid loss of the lyophilized pellet
and add exactly 1.0 mL of
deionized water. Replace stopper
and gently swirl. | and mix well until dissolution is
complete. Swirl gently to mix
before each use. |
| | Leave to stand for 5 minutes. Swirl
each vial just prior to use. Avoid
foaming. | |
| Stability | Lyophilized:
Stable at 2-8°C up to expiry date
indicated on the package
labelling.
Reconstituted material:
Stable 7 days when stored at
2-8°C, if contamination is avoided
and vials are recapped
immediately after use. | Lyophilized:
Stable at 2-8°C until expiration
date displayed on label.
Reconstituted material:
Stable for at least 7 days when
stoppered and stored at 2-8°C. |
| Levels | Single Level | Single Level |
| Constituent
Analyte(s) | Angiotensin Converting Enzyme
(ACE) | Angiotensin Converting Enzyme
(ACE) |
| Differences | | |
| No significant differences identified | | |
KD 10001:2008 - ISO 13465.2012 vari 150 13465.2008 CRIPCMS - 80 QHONG 12801: 2904
ಿ ಟ್ಟಾಡ, ಮಾಡಿಗೆಯ ಮೊತ್ತಿಗಳು ಮತ್ತು ಸಾಂಧರಿ ಹಾ. ಯಾರಾ
3
Image /page/3/Picture/0 description: The image shows the words "SENTINEL DIAGNOSTICS" in all caps. The word "SENTINEL" is in a larger, bolder font than the word "DIAGNOSTICS." The words are arranged in two rows, with "SENTINEL" on the top row and "DIAGNOSTICS" on the bottom row. The font is sans-serif.
Summary of Performance Testing:
(1) Traceability
The Sentinel ACE Calibrator was value assigned using an in-house protocol whereby proficiency survey material from the College of American Pathologists (CAP) ACE program, which has assigned values for the Trinity ACE readent system, was used to assign a value to the Sentinel master calibrator. The value assignment involved running at least two runs per day over two days on two Abbott Architect analyzers using Sentinel ACE Liquid assay. Five replicates of pooled ACE calibrator were analyzed on each run to give a total of 20 replicates. The assigned value was the mean of the 20 replicates.
The assigned value was then verified by running commercially available control sera for ACE as well as available ACE proficiency survey material from CAP and WEQAS (Wales External Quality Assurance Scheme).
Defined acceptance criteria was met for the value assignment and verification process.
No internationally recognised certified reference material or method is available for the measurement of ACE. As such the Sentinel ACE Calibrator targeted traceability to the Trinity Biotech ACE reagent system, which is considered to be a market leader in the determination of Angiotensin Converting Enzyme activity.
(2) Stability
(i) Shelf-life Stability
Real time stability data was presented on 2 different batches of ACE Calibrator. Accelerated heat stress testing was not performed on the calibrator as the angiotensin converting enzyme in the calibrator is heat labile and therefore not stable at elevated temperatures.
At time of manufacture, calibrator was reconstituted with 1 mL of deionised water and tested on a Cobas Mira, using Trinity Biotech ACE reagent. The calibrator recovery value represented the initial time result.
After 46 months (batch # 1) and 38 months (batch # 2) storage at 2-8°C as a lyophilized and capped fill, the Calibrator was re-tested after being reconstituted with deionised water and stored for 7 days at 2-8°C. The calibrator mean recovery result after 46 and 38 months respectively was compared against the initial time result (at time of manufacture) and % bias versus initial time result calculated.
The data demonstrates that the un-reconstituted calibrator when stored sealed at 2-8°C is stable for at least 38 months. Based on the shelf life data presented, the claimed shelf will be 36 months (3 years) from date of manufacture, which is the same shelf life as claimed by the predicate device.
4
Image /page/4/Picture/0 description: The image shows the words "SENTINEL DIAGNOSTICS" in all capital letters. The word "SENTINEL" is in a larger, bolder font than the word "DIAGNOSTICS", which is directly below it. The text is black against a white background.
(ii) Reconstituted Stability (Open vial)
3 vials of ACE Calibrator were reconstituted with 1 mL of deionised water as instructed on the package insert and pooled into a single vial. The pooled calibrator was then stored at 2-8°C for at least 7 days.
ACE Calibrator reconstituted for 7 days at 2-8℃ was tested against freshly reconstituted ACE calibrator. Sentinel ACE Liquid assay was used for testing together with approved instrument application on the Abbott Architect analyzer. Freshly reconstituted calibrator was used to calibrate the ACE assay. ACS ACE Controls were run as Quality Control material. The calibrator and controls were run in triplicate.
In addition to 7 days, calibrator was also tested at day 2 and day 8 (stored at 2-8°C).
The recovery of the freshly reconstituted calibrator was compared to the recovery of calibrator stored for 7 days refrigerated at 2-8°C.
The results demonstrated that the ACE Calibrator met the acceptance criteria of within ± 5.0% difference in ACE recoveries between fresh calibrator and calibrator reconstituted and stored for 7 days at 2-8°C.
The reconstituted ACE Calibrator is stable and can be used for up to 7 days when stored capped and refrigerated at 2-8°C.
Conclusion:
The Sentinel ACE Calibrator and the Analytical Control Systems ACE Calibrator (predicate device) are substantially equivalent .
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2014
SENTINEL CH. SPA PATRICIA DUPE REGULATORY AFFAIRS MANAGER VIA ROBERT KOCH, 2 MILANO 20152 ITALY
Re: K141728
Trade/Device Name: ACE Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: June 19, 2014 Received: June 26, 2014
Dear Ms. Patricia Dupé:
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. Iisting 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2-Ms. Duné
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 80) 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141728
Device Name ACE Calibrator
Indications for Use (Describe)
The ACE Calibrator is a device intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensing enzyme (ACE) assay in human serum or plasma. The product is for in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Yung W. Chan -S
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