MODIFICATION TO SENTINEL CLIN CHEM CAL

K070971 · Sentinel Ch. Srl · JIX · May 23, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070971
• Device Name: MODIFICATION TO SENTINEL CLIN CHEM CAL
• Applicant: Sentinel Ch. Srl
• Product Code: JIX · Clinical Chemistry
• Decision Date: May 23, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Multiparameter calibrator [CCC-S] for quantitative clinical chemistry determinations. Sentinel Clin Chem Cal must be used for the calibration of clinical chemistry tests. The Sentinel Clin Chem Cal is a device intended for medical purposes for use in Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" assays to establish points of reference that are used in the determination of values in the measurement of Pancreatic amylase, Cholinesterase, Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucaine-Inhibited" in human specimens.

Device Story

Sentinel Clin Chem Cal is a lyophilized, human serum-based calibrator; used to calibrate clinical chemistry assays on automated systems (e.g., Abbott ARCHITECT c8000). The device provides reference values for pancreatic amylase, cholinesterase, creatinine, lithium, and alpha-hydroxybutyrate dehydrogenase. The calibrator is reconstituted by the laboratory technician and processed alongside controls and master lots to establish target values. By ensuring accurate calibration, the device enables clinical chemistry analyzers to provide precise quantitative results for patient samples, supporting diagnostic decision-making by healthcare providers.

Clinical Evidence

No clinical data. Bench testing only. Performance supported by traceability to NIST SRM909b, DGKC, and IFCC standards. Stability testing confirms 24-month shelf life and 2-day reconstituted stability at 2-8°C (or 14 days at -20°C). Value assignment performed in-house on clinical chemistry analyzers using triplicate testing across four runs; imprecision maintained below 4.5%.

Technological Characteristics

Lyophilized human serum-based calibrator. Traceable to NIST SRM909b, DGKC/37°C, and IFCC EPS/37°C standards. Storage: 2-8°C. Analyzers: Abbott Aeroset and Abbott Architect. No software or electronic connectivity.

Indications for Use

Indicated for use as a calibrator to establish reference points for the quantitative measurement of pancreatic amylase, cholinesterase, creatinine, lithium, alpha-hydroxybutyrate dehydrogenase, and cholinesterase dibucaine-inhibited in human serum specimens. For professional use in clinical chemistry settings.

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

• Sentinel Clin Chem Cal (k051452)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k070971

B. Purpose for Submission:
New device with the addition of new analytes to a multi-analyte calibrator material

C. Measurand:
Amylase, cholinesterase, creatinine, lithium, alpha-hydroxybutyrate, and dibucaine-inhibited cholinesterase

D. Type of Test:
Calibrator materials

E. Applicant:
Sentinel CH.

F. Proprietary and Established Names:
Sentinel Clin Chem Cal

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150, Calibrator
2. Classification:
Class II
3. Product code:
JIX, Multi-Analyte Calibrator

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4. Panel:
75, Chemistry

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
Clinical Chemistry- The Sentinel Clin Chem Cal is a device intended for medical purposes for use in Pancreatic amylase, cholinesterase, creatinine, lithium, alpha-hydroxybutyrate dehydrogenase and “cholinesterase dibucaine-inhibited” assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase, cholinesterase, creatinine, lithium, alpha-hydroxybutyrate dehydrogenase and “cholinesterase dibucaine-inhibited” in human specimens.

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
Abbott Aeroset and Abbott Architect Analyzers

I. Device Description:
The Sentinel Clin Chem Cal is an in vitro diagnostic device intended for use in pancreatic amylase, cholinesterase, creatinine, lithium, alpha-hydroxybutyrate dehydrogenase and “cholinesterase dibucaine-inhibited” assays to establish points of reference that are used in the determination of values in the measurement of pancreatic amylase, cholinesterase, creatinine, lithium, alpha-hydroxybutyrate dehydrogenase and “cholinesterase dibucaine-inhibited” in human specimens. The device consists of lyophilized material in human based serum. The human serum used has been tested and found to be non-reactive for HBsAg, anti-HIV 1/2 and anti-HCV.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Sentinel Clin Chem Cal

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2. Predicate 510(k) number(s):

k051452

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Clin Chem Cal must be used only for the calibration of clinical chemistry test. | Same |
| Storage | 2 to 8°C | Same |
| Stability | 2 days when stored at 2 to 8°C.
14 days at -20°C if aliquoted in small volumes | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Components | Cholinesterase
Cholinesterase
Dibucaine-Inhibited
Pancreatic
Amylase
Creatinine
Alpha beta hydroxybutyrate dehydrogenase
Lithium | Cholinesterase, Pancreatic α-amylase, Creatinine, Alpha beta hydroxybutyrate dehydrogenase, Acid phosphatase, Albumin, α-amylase, Alkaline phosphatase, Alanine aminotransferase, Asparate aminotransferase, Direct bilirubin, Calcium, Cholesterol, Creatine kinase, Iron, γ- glutamytransference, Glucose, Lactate, Lactate dehydrogenase, Lipase, Magnesium, Phosphorus, Salicylate, Triglycerides, Total protein, Uric Acid, UIBC, Urea |

K. Standard/Guidance Document Referenced (if applicable):

FDA’s Guidance for Industry, Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators, February 22, 1999.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

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b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The Sentinel Clin Chem Cal is traceable to the following:

| Analytes | Method | Standardization |
| --- | --- | --- |
| Cholinesterase | Deutsche Gesellschaft fur Kinische Chemie (DGKC) Butyrylthiocholine 37° | ε Hexacyano-ferrate (III) |
| Cholinesterase Dibucaine-Inhibited | Deutsche Gesellschaft fur Kinische Chemie (DGKC) Dibucaine.inhibited liquid | ε Hexacyano-ferrate (III) |
| Pancreatic Amylase | International Federation of Clinical Chemistry (IFCC) EPS / 37° | p-Nitrophenol |
| Creatinine | Enzymatic Colorimetric | NIST, SRM909b |
| Lithium | Colorimetric Substituted Porphyrin | NIST, SRM909b |
| Alpha-hydroxybutyrate dehydrogenase | DGKC/37° | ε NADH |

Values are assigned in-house on commercially marketed clinical chemistry analyzers. Each testing run evaluates triplicates of the following: two levels of control materials (low and high), an aliquot of internal master lot and two aliquots of two pools of calibrator materials. Four runs on at least two different days are performed. The mean and the standard deviation of the two calibrator pools were calculated. The assigned value was determined to be the mean of the two calibrator pools barring any outlier and imprecision of less than 4.5%.

The sponsors' results support the shelf-life stability claim of up to 24 month and a reconstituted stability material claim of 2 days at 2 to 8°C or 14 days at -20°C when stored in small volumes and frozen once.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

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Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.