(47 days)
No
The document describes a chemical calibrator and does not mention any AI or ML components or functionalities.
No
Explanation: The device is a calibrator used in diagnostic assays to establish points of reference for measuring substances in human specimens, not to treat or prevent a disease.
No
Explanation: The device is described as a calibrator used to establish points of reference for the determination of values in assays, not to directly diagnose a condition or disease.
No
The device description explicitly states it is a "lyophilized Calibrator prepared with human based serum" and consists of "bottles of lyophilized material," indicating it is a physical product, not 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, 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..." These are all measurements performed in vitro on human specimens.
- Device Description: The device is a "lyophilized Calibrator prepared with human based serum." Calibrators are used in laboratory tests to ensure the accuracy of the measurements.
- Specimen Type: The device is used with "human specimens."
- Purpose: The purpose is to "establish points of reference that are used in the determination of values in the measurement of..." This is a core function of a calibrator used in in vitro diagnostic testing.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
Original (Clin Chem Cal K051452).
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- The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase in a lyophilised human serum matrix. This material is stable until the date printed on the label when stored as directed. Calibrator traceability was stated as certified to Deutsche Gesellschaft für Klinische Chemie (DGKC) for Cholinesterase
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- International Federation of Clinical Chemistry (IFCC) for Pancreatic Amylase
Modified Clin Chem Cal
The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucainedi in a lyophilized human serum matrix. This material is stable until the date printed on the label when stored as directed. Calibrator traceability was stated as certified to
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- Deutsche Gesellschaft für Klinische Chemie (DGKC) for Cholinesterase, Cholinesterase Dibucaine-Inhibited and for Alpha-hydroxybutyrate Dehydrogenase
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- International Federation of Clinical Chemistry (IFCC) for Pancreatic Amylase
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- NIST, SRM 909b for Creatinine and Lithium.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified CLIN CHEM CAL assay is substantially equivalent to the Predicate Device and to the previous Cleared CLIN CHEM CAL as demonstrated by results obtained in the studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 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
MAY 2 3 2007
510(k) Summary
Submitter's Name/Address SENTINEL CH. Via Robert Koch, 2 20152 Milano - Italy
Contact Person
Fabio Rota Technical Director Regulatory Affairs Tel. +39 02 34551448 Fax: +39 02 34551464
| Date of Preparation of this Summary: | March 30, 2007 |
|---|---|
| Device Trade or Proprietary Name: | Sentinel Clin Chem Cal |
| Device Common/Usual Name or | |
| Classification Name: | CLIN CHEM CAL |
| 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:
Device Description:
Original (Clin Chem Cal K051452).
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- The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase in a lyophilised human serum matrix. This material is stable until the date printed on the label when stored as directed. Calibrator traceability was stated as certified to Deutsche Gesellschaft für Klinische Chemie (DGKC) for Cholinesterase
-
- International Federation of Clinical Chemistry (IFCC) for Pancreatic Amylase
1
Modified Clin Chem Cal
The Sentinel Clin Chem Cal is a lyophilized Calibrator prepared with human based serum. It consists of 4 x 3 mL bottles of lyophilized material containing pancreatic amylase, cholinesterase Creatinine, Lithium, Alpha-Hydroxybutyrate Dehydrogenase and "Cholinesterase Dibucainedi in a lyophilized human serum matrix. This material is stable until the date printed on the label when stored as directed. Calibrator traceability was stated as certified to
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- Deutsche Gesellschaft für Klinische Chemie (DGKC) for Cholinesterase, Cholinesterase Dibucaine-Inhibited and for Alpha-hydroxybutyrate Dehydrogenase
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- International Federation of Clinical Chemistry (IFCC) for Pancreatic Amylase
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- NIST, SRM 909b for Creatinine and Lithium.
Description of modifications:
The modified CLIN CHEM CAL assay is substantially equivalent to the original CLN CHEM CAL assay K051452. The modifications consisted of certification in the following new analytes
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- Lithium
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- Creatinine
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- Cholinesterase Dibucaine-Inhibite
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- Alpha Bota Hydroxybutyrate Dehydrogenase.
All the above listed analytes are already contained in the original CLIN CHEM CAL. Thus no modifications of the chemical's compositions nor the production procedures have been made for the Clin Chem Cal (K051452).
These modifications did not significantly change the safety and effectiveness of the device as demonstrated in the Performance Characteristics Summary.
2
Intended Use:
Multiparameter calibrator [CCC-S] for quantitative clinical chemistry determinations. Sentinel Clin Chem Cal must be used for the calibration of clinical chemistry tests.
Description of the Calibrator Material:
Sentinel Clin Chem Cal contains the analytes in a lyophilized human serum matrix. The analytes consist of:
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- Pancreatic Amylase
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- Cholinesterase
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- Cholinesterase Dibucaine-inhibited
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- Lithium
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- Creatinine
- Alpha-Beta Hydroxybutyrate Dehydrogenase. 6.
Assigned Values and Value Assignment Process:
Target value assignment procedure is described in internal official protocol and under defined conditions.
Thirty (30) randomly selected vials of calibrator are reconstituted by weight (acceptability 2.970-3.030 g) following the Instruction for Use. (See page 28) for draft Instructions for Use)
The reconstituted vials are pooled in two (2) pools (15 vials in pool A and 15 different vials in pool B). The pools are aliquoted in small volumes (800 - 1200 µL) and the aliquots are labelled and stored at -20 ℃.
On Abbott ARCHITECT® c8000 System (K980367), the following assays:
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- Pancreatic Amylase
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- Cholinesterase
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- Cholinesterase Dibucaine-inhibited
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- Lithium
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- Creatinine
- Alpha-Beta Hydroxybutyrate Dehydrogenase. 6.
Clin Chem Cal 510(k) March 30, 2007
3
are calibrated against an Internal Master Lot, stored at -20 ℃ and freshly thawed. During each testing run the following samples are tested:
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- Two levels (normal and abnormal) of control materials in triplicate to ensure the effectiveness of the measurements
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- Aliquot of Internal Master lot in triplicate
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- Aliquots of pool A and Pool B in triplicate.
Four (4) analytical runs on at least two different days are performed. Single run is accepted if % recovery of each control material is within 85% - 115% and if % recovery of Internal Master lot is within 95%-105%.
The mean and Standard Deviation and %CV of the all measurements of pool A and Pool B are calculated. Data are inspected for outlier detection (single data - Mean > 3SD) and for imprecision of the measurements according to predefined criteria. In case of absence of outliers and of imprecision