SENTINEL CLIN CHEM CAL

K051452 · Sentinel Ch. Srl · JIX · Oct 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051452
• Device Name: SENTINEL CLIN CHEM CAL
• Applicant: Sentinel Ch. Srl
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 25, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended 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. For Prescription Use Only

Device Story

Sentinel Clin Chem Cal is a multi-analyte calibrator consisting of pancreatic amylase and cholinesterase in a human serum matrix. It is used in clinical chemistry laboratories to establish reference points for the measurement of these analytes in human serum and plasma. The device is provided in vials that require reconstitution with distilled water. Value assignment is performed by assaying the calibrator on Hitachi 717 and Abbott ARCHITECT c8000 instruments, with the final assigned value being the mean of the averages from both systems. Healthcare providers use the calibrated assay results to determine patient analyte levels, aiding in clinical decision-making related to pancreatic and cholinesterase function. The calibrator ensures the accuracy and effectiveness of clinical chemistry measurements.

Clinical Evidence

No clinical data. Bench testing only. Stability was validated through real-time studies confirming 24-month shelf life and 2-day stability at 2-8°C post-reconstitution. Value assignment was performed using commercially marketed analyzers with internal control monitoring.

Technological Characteristics

Multi-analyte calibrator in human serum matrix. Analytes: pancreatic amylase and cholinesterase. Traceability: IFCC EPS/37°C for amylase (p-Nitrophenol standard) and DGKC Butyrylthiocholine/37°C for cholinesterase (Hexacyano-ferrate (III) standard). Form factor: lyophilized powder in vials, reconstituted with distilled water. Storage: -20°C for long-term, 2-8°C for short-term after reconstitution.

Indications for Use

Indicated for use as a calibrator in pancreatic amylase and cholinesterase assays for human serum and plasma samples.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• Roche Calibrator for Automated Systems (k033501)

Submission Summary (Full Text)

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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: [phone] Facsimile: +39 02 345514.64 E-Mail: [e-mail]

| 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.

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#### 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

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#### Performance Characteristics:

- 1. Precision/Reproducibility
N/A

#### 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<br>Amylase | IFCC EPS / 37 °C | $\varepsilon$ p-Nitrophenol |
| ChE | Cholinesterase | DGKC Butyrylthiocholine<br>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

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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.

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# Table 1 Sentinel Sentinel Clin Chem Cal Real Time Stability - Pancreatic Amylase and Cholinesterase

| Time | Cholinesterase<br>(U/L) | P - Amylase<br>(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 |

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### 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<br>1) The D% (factor and controls) between days must be less 5%<br>2) 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<br>(2-8°C) | 14 days<br>(-20°C) | | | | |
| sample | supplier | lot | Expired date | time of<br>valutation | expected<br>value | replicates | value | value | %R<br>(2d vs To) | value | D%<br>(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<br>manufacturing | 151 | factor | 3226 | 3378 | 4.7% | 3319 | 2.9% | | |
| Precinom U | Roche | apr/2004 | still valid | 12 months<br>after<br>manufacturing | 39 ±7 | 1 | 42 | 40 | | 43 | | | |
| | | | | | | 2 | 39 | 39 | | 37 | | | |
| | | | | | | 3 | 37 | 41 | | 38 | | | |
| Precipath U | roche | feb/2004 | still valid | 14 months<br>after<br>manufacturing | 102 ± 18 | 1 | 108 | 103 | | 107 | | | |
| | | | | | | 2 | 106 | 107 | | 102 | | | |
| | | | | | | 3 | 105 | 105 | | 109 | | | |
| mean | | control | | Precinom U<br>Precipath U | | Roche<br>roche | apr/2004<br>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<br>(2-8°C) | | 14 days<br>(-20°C) | | |
| sample | supplier | lot | Expired date | time of<br>valutation | expected<br>value | replicates | value | value | %R<br>(2d vs To) | value | %R<br>(30d vs To) | | |
| | | M0750 | sep/2002 | 13 months<br>expired | 183<br>target NA | 1 | 191 | 197 | | 204 | | | |
| | | | | | | 2 | 184 | 201 | | 198 | | | |
| | | | | | | 3 | 199 | 194 | | 194 | | | |
| Clin Chem Cal | Sentinel | M0796 | jan/2003 | 8 months<br>expired | 172<br>target NA | 1 | 180 | 185 | | 183 | | | |
| | | | | | | 2 | 173 | 187 | | 188 | | | |
| | | | | | | 3 | 186 | 178 | | 185 | | | |
| | | P0690 | jun/2006 | still valid | 151<br>target NA | 1 | 153 | 155 | | 154 | | | |
| | | | | | | 2 | 150 | 155 | | 157 | | | |
| | | | | | | 3 | 153 | 150 | | 153 | | | |
| Mean | | calibrator | Clin Chem Cal | Sentinel | M0750<br>M0796<br>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 :<br>2 days at 2-8°C or 14 days at -20°C | | | | | | | | | | |
| QC (date Signature) | | 02/10/2003 | | | | | | | | | | | |
| | | | | | | | | | Ezio Marelli<br>Technical Manager<br>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

.

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# Table 3 Sentinel Sentinel Clin Chem Cal After Reconstitution Stability – Cholinesterase

| | | | STABILITY AFTER RECOSTITUTION | | | | | | | SENTINEL | |
|------------------------------------------------------------|---------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------|-------------------------|----------------------|------------------|---------------------------------------------------|-------------------|
| product: | Clin chem Cal<br>ref 16550<br>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<br>exp : jul/2006 | | | | |
| | Clin Chem Cal | | | REF 16550<br>lot | | | 3 differents lots | | | | |
| Calibration/Check system: | | | | Acceptability criteria<br>1) The D% (factor and controls) between days must be less 5%<br>2) 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<br>(2-8°C) | | 14 days<br>(-20°C) | |
| sample | supplier | lot | Expired date | time of<br>valutation | expected<br>value | replicates | value | value | D%<br>(2d vs To) | value | D%<br>(30d vs To) |
| blank | | | | | | Dabs | -0.0036 | -0.0029 | | -0.0031 | |
| calibrator | Sentinel | P0690 | jun / 2006 | 2 months after<br>manufacturing | 5920 | Dabs<br>factor | 0.0399<br>-87774 | -0.0396<br>-86817 | -1.1% | -0.0407<br>-84724 | -3.5% |
| Precinorm U | Roche | apr/2004 | still valid | 12 months<br>after<br>manufactoring | 6700 ± 1100 | 1<br>2<br>3 | 6721<br>6641<br>6734 | 6641<br>6701<br>6851 | | 6638<br>6703<br>6890 | |
| Precipath U | roche | feb/2004 | still valid | 14 months<br>after<br>manufacturing | 6300 ± 1000 | 1<br>2<br>3 | 6278<br>6273<br>6185 | 6286<br>6340<br>6204 | | 6245<br>6269<br>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<br>(2-8°C) | | 14 days<br>(-20°C) | |
| sample | supplier | lot | Expired date | time of<br>valutation | expected<br>value | replicate | value | value | D%<br>(2d vs To) | value | D%<br>(30d vs To) |
| | | M0750 | sep/2002 | 13 months<br>expired | 4850<br>target NA | 1<br>2<br>3 | 4677<br>4785<br>4891 | 4677<br>4785<br>4891 | | 4868<br>4754<br>4661 | |
| Clin Chem Cal | Sentinel | M0796 | jan/2003 | 8 months<br>expired | 5010<br>target NA | 1<br>2<br>3 | 5001<br>5014<br>5104 | 5001<br>5014<br>5104 | | 5101<br>5007<br>4980 | |
| | | P0690 | jun/2006 | still valid | 5920<br>target NA | 1<br>2<br>3 | 5821<br>5811<br>5945 | 5821<br>5811<br>5945 | | 5904<br>5801<br>5901 | |
| Mean | calibrator | | Clin Chem Cal | Sentinel | M0750<br>M0796<br>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 :<br>2 days at 2-8°C or 14 days at -20°C | | | | | | | | |
| QC (date Signature) | | 02/10/2003 | | | | | | | | Ezio Marelli<br>Technical Manager<br>SENTINEL CH. | |
| | | SENTINEL<br>DACNU | SENTINEL CH<br>Via Principe Eugenio, 5 20155 Milano, Italy<br>Ph. [phone] Fax [phone] www.sentinel.it [e-mail] | | | | | | | | |

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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).

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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 [phone]. 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 [phone] or [phone] 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

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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

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Office of In Vitre Diagnostic Device Evaluation and Sulety

051450