(145 days)
Not Found
Not Found
No
The document describes a chemical calibrator for laboratory assays and does not mention any computational or algorithmic components, let alone AI/ML.
No
The device is a calibrator used in diagnostic assays to establish points of reference for measuring substances in human serum and plasma, not to treat a medical condition.
No
The device is described as a "calibrator." It is used to "establish points of reference" for assays, not to directly diagnose a condition.
No
The device description explicitly states that the device "contains the analytes in human serum matrix," indicating a physical component (the calibrator material) is part of the device, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma." This describes a product used in vitro (outside the body) to analyze human samples for diagnostic purposes.
- Device Description: The description reinforces this by stating it "contains the analytes in human serum matrix" and is used in assays to measure these analytes in human serum and plasma.
- Performance Studies: The performance studies focus on the stability and traceability of the calibrator, which are key characteristics evaluated for IVD devices to ensure accurate and reliable results in diagnostic testing.
- Predicate Device: The mention of a "Predicate Device" (Roche) is common in regulatory submissions for IVD devices, where a new device is compared to an already approved device.
The core function of this device is to provide a reference standard for in vitro tests performed on human biological samples to aid in diagnosis or monitoring. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
Sentinel Clin Chem Cal contains the analytes in human serum matrix. The analytes consist of pancreatic amylase and cholinesterase.
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)
Performance Characteristics:
-
- Precision/Reproducibility: N/A
-
- Linearity/assay reportable range: N/A
-
- Traceability (controls, calibrators, or method): The Sentinel Clin Chem Cal is traceable to the following referenced standards:
- AmyP (Pancreatic Amylase): Method - IFCC EPS / 37 °C, Standardization - ε p-Nitrophenol
- ChE (Cholinesterase): Method - DGKC Butyrylthiocholine 37 °C, Standardization - ε Hexacyano-ferrate (III)
-
- Detection limit (functional sensitivity): N/A
-
- Analytical specificity: N/A
-
- Assay cut-off: N/A
-
- Calibrator Shelf-life Stability: Determined by recovery method on one lot of Sentinel Clin Chem Cal. Stored at 4℃. Percent recovery calculated for each calibrator level by dividing result of test calibrator at time zero by result of control calibrators at every testing point. Target recovery was 95% to 105%. Results show calibrators are stable for up to 33 months. Claimed shelf life is 24 months from date of manufacture, which is the same as the predicate device (Roche).
-
- Calibrator After Reconstitution Stability: Assessed on three lots of calibrator: one expired from 13 months, one expired from 8 months, and one still in validity. Determined by recovery method. Percent recovery calculated for each calibrator analyte by dividing results of reconstituted vial stored at 2--8 ℃ after 2 days, and at -20 ℃ after 14 days by results of a freshly reconstituted vial of the same lot. Acceptance criteria is 100 ± 7%. Stability of reconstituted material: 2 days at 2 to 8 °C or 14 days at -20 °C if aliquoted in small volumes.
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.
Not Found
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
001 25 2005
510(k) Summary
Submitter's Name/Address Sentinel CH. Srl Via Principe Eugenio 5 20155 Milan - ITALY
Contact Person
Mr. Davide Spada Application Specialist Telephone: +39 02 345514.1 Facsimile: +39 02 345514.64 E-Mail: spada@sentinel.it
| Date of Preparation of this Summary: | May, 28 2005 |
|---|---|
| Device Trade or Proprietary Name: | Sentinel Clin Chem Cal |
| Device Common/Usual Name or Classification Name: | Calibrator |
| Classification Number/Class: | JIX/Class II |
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _KOS 1452
Test Description:
The Sentinel Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.
Intended Use:
Sentinel Clin Chem Cal must be used only for the calibration of clinical chemistry tests.
1
Description of the Calibrator Material:
Sentinel Clin Chem Cal contains the analytes in human serum matrix. The analytes consist of pancreatic amylase and cholinesterase.
Assigned Values and Value Assignment Process:
Four vials of calibrator are reconstituted by weight (acceptability 2.970-3.030 g) following the Instruction for Use.
To evaluate vial variability, Pancreatic Amylase is assayed in three replicates on each vial and %CV is calculated for each vial. If %CV is equal to or greater than 4.5%, the vial is discarded from the analysis. At least 2 vials of calibrator can be used. If more than 3 vials are discarded, another set of four calibrator must be used.
The pool of all accepted vials is aliquoted in small volumes and stored at -20 ℃.
The Pancreatic Amylase and Cholinesterase assay are calibrated against the previous calibrator lot, stored at 2-8 ℃ and freshly reconstituted. During each testing run, two levels (normal and abnormal) of control materials are assayed to ensure the effectiveness of the measurements.
For three consecutive days (three runs), three replicates of Pancreatic Amylase and Cholinesterase are assayed on Hitachi 717. The average of all replicates is calculated (X1).
Pancreatic Amylase and Cholinesterase are also assayed on Abbott ARCHITECT® c8000 . Five vials of freshly reconstituted by weight vials are assayed in five replicates on c8000. The average of all replicates is calculated (X2).
The assigned value (Xm) is the mean of the two average: Xm=(X1+X2)/2
Directions for Use:
Refer to Draft Calibrator Labeling on page 17
2
Performance Characteristics:
-
- Precision/Reproducibility
N/A
- Precision/Reproducibility
2. Linearity/assay reportable range
N/A
3. Traceability (controls, calibrators, or method)
The Sentinel Clin Chem Cal is traceable to the following referenced standards:
| Analyte | Method | Standardization | |
|---|---|---|---|
| AmyP | Pancreatic | ||
| Amylase | IFCC EPS / 37 °C | $\varepsilon$ p-Nitrophenol | |
| ChE | Cholinesterase | DGKC Butyrylthiocholine | |
| 37 °C | $\varepsilon$ Hexacyano-ferrate (III) |
4. Detection limit (functional sensitivity)
N/A
5. Analytical specificity
N/A
6. Assay cut-off
N/A
7. Calibrator Shelf-life Stability
The calibrator shelf-life stability was determined by the recovery method on one lots of Sentinel Clin Chem Cal. One lot of test calibrator were stored at 4℃. At the time of analysis was reconstituted with distilled water. Percent recovery was calculated for each calibrator level by dividing the result of the test calibrator at
3
Image /page/3/Picture/0 description: The image shows two handwritten phrases. The phrase on the left appears to say "Hand made". The phrase on the right is more difficult to read, but it seems to say "with love".
time zero by the result of control calibrators at every testing point. At each testing point, fresh reagent, control calibrators, and test calibrators were analyzed. Calibrators were tested at multiple test points through a minimum of 30 months. Target recovery was 95% to 105% for the test calibrators as compared to the Time zero. Results are found in Table 1.
The results show the calibrators are stable for up to 33 months. The resulting claim is 24 months from date of manufacture.
Since the calibrator is purchased from Roche which is the Predicate Device for ビ the Sentinel Clin Chem Cal, Shelf life of the calibrator is the same as the Predicate Device.
8. Calibrator After Reconstitution Stability
After Reconstitution stability was assessed on three lots of calibrator: one expired from 13 months (expiry date + 13 months), one expired from 8 months (expiry date + 8 months) and one still in validity.
The calibrator after reconstitution stability was determined by the recovery method. Percent recovery was calculated for each calibrator analyte by dividing the results of the reconstituted vial stored at 2 -- 8 ℃ after 2 days, and at -20 ℃ after 14 days by the results of a freshly reconstituted vial of the same lot. At each test point fresh reagents were used.
Acceptance criteria is 100 ± 7%.
Results are found in Table 2 and Table 3.
Stability of reconstituted material: 2 days at 2 to 8 °C or 14 days at -20 °C if aliquoted in small volumes.
4
Table 1 Sentinel Sentinel Clin Chem Cal Real Time Stability - Pancreatic Amylase and Cholinesterase
| Time | Cholinesterase
(U/L) | P - Amylase
(U/L) |
|----------|-------------------------|----------------------|
| 0 Monhts | 4581 | 148.8 |
| 1 Mo | 4618 | 150.6 |
| % Rec | 100.8 | 101.2 |
| 4 Mo | 4627 | 151.3 |
| % Rec | 101.0 | 101.7 |
| 8 Mo | 4590 | 152.4 |
| % Rec | 100.2 | 102.4 |
| 11 Mo | 4636 | 150.6 |
| % Rec | 101.2 | 101.2 |
| 14 Mo | 4503 | 144.6 |
| % Rec | 98.3 | 97.2 |
| 17 Mo | 4595 | 151.0 |
| % Rec | 100.3 | 101.5 |
| 20 Mo | 4485 | 151.5 |
| % Rec | 97.9 | 101.8 |
| 23 Mo | 4508 | 147.2 |
| % Rec | 98.4 | 98.9 |
| 26 Mo | 4576 | 150.0 |
| % Rec | 99.9 | 100.8 |
| 29 Mo | 4663 | 154.2 |
| % Rec | 101.8 | 103.6 |
| 33 Mo | 4636 | 148.7 |
| % Rec | 101.2 | 99.9 |
5
Table 2
Sentinel Sentinel Clin Chem Cal After Reconstitution Stability - Pancreatic Amylase
| product: | Clin chem Cal | ref 16550 | at 2-8°C and - 20°C | SENTINEL | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Used Material | |||||||||||||
| Instrument. | HITACHI 717 | 17631 | lot | 31147 | exp : mar/2005 | ||||||||
| reagent lot | Pancreatic amylase | exp : jun/2006 | |||||||||||
| Clin Chem Cal | REF 16550 | lot | P0690 | ||||||||||
| Clin Chem Cal | REF 16550 | lot | 3 differents lots | ||||||||||
| Calibration/Check system: | Acceptability criteria |
- The D% (factor and controls) between days must be less 5%
- all replicates of controls must be in the target range | | | | | | | | | |
| Stability after recostitution Calibrator: | | | | | | | 1) The % Recovery (%R) between days must range 93-107% | | | | | | |
| | | | | Calibration /Check system (reagents+ instruments) | | | time 0 | 2 days
(2-8°C) | 14 days
(-20°C) | | | | |
| sample | supplier | lot | Expired date | time of
valutation | expected
value | replicates | value | value | %R
(2d vs To) | value | D%
(30d vs To) | | |
| blank | | | | | | Dabs | 0.0005 | 0.0002 | | 0.0000 | | | |
| | | | | | | Dabs | 0.0473 | 0.0449 | | 0.0455 | | | |
| calibrator | Sentinel | P0690 | jun / 2006 | 2 months after
manufacturing | 151 | factor | 3226 | 3378 | 4.7% | 3319 | 2.9% | | |
| Precinom U | Roche | apr/2004 | still valid | 12 months
after
manufacturing | 39 ±7 | 1 | 42 | 40 | | 43 | | | |
| | | | | | | 2 | 39 | 39 | | 37 | | | |
| | | | | | | 3 | 37 | 41 | | 38 | | | |
| Precipath U | roche | feb/2004 | still valid | 14 months
after
manufacturing | 102 ± 18 | 1 | 108 | 103 | | 107 | | | |
| | | | | | | 2 | 106 | 107 | | 102 | | | |
| | | | | | | 3 | 105 | 105 | | 109 | | | |
| mean | | control | | Precinom U
Precipath U | | Roche
roche | apr/2004
feb/2004 | | 39.3 | 40.0 | 1.7% | 39.3 | 0.0% |
| | | | | | | | | 106.3 | 105.0 | -1.3% | 106.0 | -0.3% | |
| The factor and controls meet the criteria of acceptability | | | | | P YES | * NO | | | | | | | |
| | | | 3 lots calibrator stability after recostitution | | | | | time 0 | 2 days
(2-8°C) | | 14 days
(-20°C) | | |
| sample | supplier | lot | Expired date | time of
valutation | expected
value | replicates | value | value | %R
(2d vs To) | value | %R
(30d vs To) | | |
| | | M0750 | sep/2002 | 13 months
expired | 183
target NA | 1 | 191 | 197 | | 204 | | | |
| | | | | | | 2 | 184 | 201 | | 198 | | | |
| | | | | | | 3 | 199 | 194 | | 194 | | | |
| Clin Chem Cal | Sentinel | M0796 | jan/2003 | 8 months
expired | 172
target NA | 1 | 180 | 185 | | 183 | | | |
| | | | | | | 2 | 173 | 187 | | 188 | | | |
| | | | | | | 3 | 186 | 178 | | 185 | | | |
| | | P0690 | jun/2006 | still valid | 151
target NA | 1 | 153 | 155 | | 154 | | | |
| | | | | | | 2 | 150 | 155 | | 157 | | | |
| | | | | | | 3 | 153 | 150 | | 153 | | | |
| Mean | | calibrator | Clin Chem Cal | Sentinel | M0750
M0796
P0690 | | 191.3 | 197.3 | 103% | 198.7 | 104% | | |
| | | | | | | | 179.7 | 183.3 | 102% | 185.3 | 103% | | |
| | | | | | | | 152.0 | 153.3 | 101% | 154.7 | 102% | | |
| Conclusion | | | The calibrator meet the acceptability criteria and the stability after recostitution is :
2 days at 2-8°C or 14 days at -20°C | | | | | | | | | | |
| QC (date Signature) | | 02/10/2003 | | | | | | | | | | | |
| | | | | | | | | | Ezio Marelli
Technical Manager
SENTINEL CH. | | | | |
| | | SENTINEL | | SENTINEL For - Via Pens no Cugemo 6 | | | | 20135 Milan - 400V | | | | | |
| | | 1 . A | | 14. 4.89 0.2 5455 141 Frex 139 0.2 (455 1464 - veww.tem*relle sentinellif | | | | | | | | | |
Sentinel Clin Chem Cal 510(k)
May 28, 2005
.
6
Table 3 Sentinel Sentinel Clin Chem Cal After Reconstitution Stability – Cholinesterase
| STABILITY AFTER RECOSTITUTION | SENTINEL | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| product: | Clin chem Cal | ||||||||||
| ref 16550 | |||||||||||
| at 2-8°C and - 20°C | |||||||||||
| Instrument. | HITACHI 717 | ||||||||||
| reagent lot | Cholinesterase liquid | REF 17019A | lot | 30863 | exp : Oct/2004 | ||||||
| Clin Chem Cal | REF 16550 | lot | P0690 | ||||||||
| exp : jul/2006 | |||||||||||
| Clin Chem Cal | REF 16550 | ||||||||||
| lot | 3 differents lots | ||||||||||
| Calibration/Check system: | Acceptability criteria |
- The D% (factor and controls) between days must be less 5%
- all replicates of controls must be in the target range | | | | | | | |
| Stability after recostitution Calibrator: | | | | | 1) The % Recovery (%R) between days must range 93-107% | | | | | | |
| | | | Calibration /Check system (reagents+ instruments) | | | | time 0 | 2 days
(2-8°C) | | 14 days
(-20°C) | |
| sample | supplier | lot | Expired date | time of
valutation | expected
value | replicates | value | value | D%
(2d vs To) | value | D%
(30d vs To) |
| blank | | | | | | Dabs | -0.0036 | -0.0029 | | -0.0031 | |
| calibrator | Sentinel | P0690 | jun / 2006 | 2 months after
manufacturing | 5920 | Dabs
factor | 0.0399
-87774 | -0.0396
-86817 | -1.1% | -0.0407
-84724 | -3.5% |
| Precinorm U | Roche | apr/2004 | still valid | 12 months
after
manufactoring | 6700 ± 1100 | 1
2
3 | 6721
6641
6734 | 6641
6701
6851 | | 6638
6703
6890 | |
| Precipath U | roche | feb/2004 | still valid | 14 months
after
manufacturing | 6300 ± 1000 | 1
2
3 | 6278
6273
6185 | 6286
6340
6204 | | 6245
6269
6265 | |
| mean | control | | Precinorm U | Roche | apr/2004 | | 6698.7 | 6731.0 | 0.5% | 6743.7 | 0.7% |
| | | | Precipath U | roche | feb/2004 | | 6245.3 | 6276.7 | 0.5% | 6259.7 | 0.2% |
| The factor and controls meet the criteria of acceptability | | | | P YES | * NO | | | | | | |
| | | | 3 lots calibrator stability after recostitution | | | | time 0 | 2 days
(2-8°C) | | 14 days
(-20°C) | |
| sample | supplier | lot | Expired date | time of
valutation | expected
value | replicate | value | value | D%
(2d vs To) | value | D%
(30d vs To) |
| | | M0750 | sep/2002 | 13 months
expired | 4850
target NA | 1
2
3 | 4677
4785
4891 | 4677
4785
4891 | | 4868
4754
4661 | |
| Clin Chem Cal | Sentinel | M0796 | jan/2003 | 8 months
expired | 5010
target NA | 1
2
3 | 5001
5014
5104 | 5001
5014
5104 | | 5101
5007
4980 | |
| | | P0690 | jun/2006 | still valid | 5920
target NA | 1
2
3 | 5821
5811
5945 | 5821
5811
5945 | | 5904
5801
5901 | |
| Mean | calibrator | | Clin Chem Cal | Sentinel | M0750
M0796
P0690 | | 4784.3 | 4784.3 | 100% | 4761.0 | 100% |
| | | | | | | | 5039.7 | 5039.7 | 100% | 5029.3 | 100% |
| | | | | | | | 5859.0 | 5859.0 | 100% | 5868.7 | 100% |
| Conclusion | | | The calibrator meet the acceptability criteria and the stability after recostitution is :
2 days at 2-8°C or 14 days at -20°C | | | | | | | | |
| QC (date Signature) | | 02/10/2003 | | | | | | | | Ezio Marelli
Technical Manager
SENTINEL CH. | |
| | | SENTINEL
DACNU | SENTINEL CH
Via Principe Eugenio, 5 20155 Milano, Italy
Ph. +39(02) 4655141 Fax +39(02) 46551454 www.sentinel.it sentinel@sentinel.it | | | | | | | | |
7
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
OCT 2 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Davide Spada Application Specialist Sentinel CH S.r.l. Via Principe Eugenio, 5 20155 Milan-Italy
Re: K051452
Trade/Device Name: Sentinel Clinical Chemistry Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Multi-Analyte Calibrator Regulatory Class: Class II Product Codc: JIX Dated: August 5, 2005 Received: August 19, 2005
Dear Mr. Spada:
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 adultcration.
If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
Page 2 --
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter whilanon you to ough indias of substantial equivalence of your device to a legally premation notification: "The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of In of quostions on the promotion and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may oount other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincercly yours,
Alberto Gutierrez Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
510(k) Number (if known): ي 05 1452
Sentinel Clin Chem Cal Device Name:
Indications For Use:
Clinical Chemistry – The Sentinel Clin Chem Cal is a device intended for medical purposes for use in pancreatic amylase and cholinesterase assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase and cholinesterase in human serum and plasma.
Prescription Use
(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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Lucy Phillips
Division Sign-Off
Page 1 of 1
Office of In Vitre Diagnostic Device Evaluation and Sulety
051450