(55 days)
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No
The summary describes a chemical reagent kit for quantitative analysis, with no mention of AI/ML components or data processing that would typically involve such technologies.
No
The device is described as an "in vitro diagnostic determination of alkaline phosphatase in human serum and plasma," indicating it is used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma," and that these measurements "are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases."
No
The device description clearly states it is a kit consisting of two reagents (R1 and R2), which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "ELITech Clinical Systems ALP IFCC SL is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma..."
- Device Description: The description details the reagents used to perform a test on biological samples (serum and plasma).
- Purpose: The intended use also mentions that the measurements are used in the "diagnosis and treatment" of various diseases, which is a key characteristic of IVD devices.
The information provided clearly indicates that this device is designed to be used outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems ALP IFCC SL is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Alkaline phosphatase or its isoenzymes measurements are used in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
Product codes (comma separated list FDA assigned to the subject device)
CJE
Device Description
The device for this submission is available as kit only. It consists of 2 reagents R1 & reagent R2.
Reagent R1 contains: 2-Amino-2-methyl-1-propanol (AMP) buffer (pH 10.45), Magnesium ions, Zinc ions.
Reagent R2 contains: p-Nitrophenylphosphate (p-NPP), sodium azide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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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)
Precision
Within run
Level 57 U/L CV= 1.3%
Level 144 U/L CV= 0.9%
Level 262 U/L CV= 0.6%
Total
Level 57 U/L CV= 4.4%
Level 144 U/L CV= 3.8%
Level 262 U/L CV= 2.9%
Method comparison
y= 1.025 x - 1 U/L
r= 0.998
range: 18 to 1005 U/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of detection (LoD): 6 U/L
Limit of quantification (LoQ): 20 U/L
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.
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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
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
SECTION 5 - 510(k) Summary
/ / /
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of sub-
stantial equivalence. | | | | |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| | The assigned 510(k) number is: K 113269 | | | | |
| Submitter
Address
Phone number
Fax number | SEPPIM S.A.S.
Zone Industrielle, 61500 SEES, FRANCE
- 33 (0)2 33 81 21 00
- 33 (0)2 33 28 77 51 | | | | |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | | | | |
| Date of Preparation | November 2nd, 2011 | | | | |
| Device names | | | | | |
| REAGENT
Trade/proprietary Name:
Common or Usual Name:
Device Class
Classification name
Product code | ELITech Clinical Systems ALP IFCC SL
Alkaline phosphatase, "ALP IFCC SL"
Class II
Alkaline phosphatase or isoenzymes test system (Sec.862.1050)
CJE- Nitrophenylphosphate, alkaline phosphatase or isoenzymes | | | | |
| Predicate device | Roche Diagnostics ALP2S (Alkaline phosphatase acc. to IFCC Gen.2) (K033185) | | | | |
| Device description | The device for this submission is available as kit only. It consists of 2
reagents R1 & reagent R2.
Reagent R1 contains: 2-Amino-2-methyl-1-propanol (AMP) buffer (pH
10.45), Magnesium ions, Zinc ions.
Reagent R2 contains: p-Nitrophenylphosphate (p-NPP), sodium azide. | | | | |
| Intended Use | ELITech Clinical Systems ALP IFCC SL is intended for the quantitative in
vitro diagnostic determination of alkaline phosphatase in human serum and
plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use In Point of Care settings. | | | | |
| Indication for use | Alkaline phosphatase or its isoenzymes measurements are used in the
diagnosis and treatment of liver, bone, parathyroid and intestinal diseases. | | | | |
1
Comparison to Predicate device
、・
| | ELITech Clinical Systems Device
(ALP IFCC SL) | Predicate device
(Roche Diagnostics ALP2S (K033185) |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Intended for the quantitative in vitro
diagnostic determination of alkaline
phosphatase in human serum and
plasma on ELITech Clinical Systems
Selectra analyzers.
It is not intended for use in Point of
Care settings. | In vitro test for the quantitative deter-
mination of alkaline phosphatase in
human serum and plasma on the co-
bas c 111 system. |
| Indication for Use | Alkaline phosphatase or its isoen-
zymes measurements are used in the
diagnosis and treatment of liver,
bone, parathyroid and intestinal di-
seases. | Alkaline phosphatase or its isoen-
zymes measurements are used in the
diagnosis and treatment of liver, bone,
parathyroid and intestinal diseases. |
| Assay protocol | Colorimetric. Kinetic.
Measurement of the rate of production
of p-nitrophenol at 405 nm.
Based on IFCC recommendations. | Colorimetric. Kinetic
Measurement of the rate of production
of p-nitrophenol at 409 nm.
Based on IFCC recommendations. |
| Composition | Reagent R1:
AMP buffer (pH 10.45)
Magnesium ions
2.4 mmol/L
Zinc ions
1.2 mmol/L | Reagent R1:
AMP buffer (pH 10.5) 1.724 mol/L
Magnesium acetate 3.83 mmol/L
Zinc sulfate 0.766 mmol/L
N-(2-hydroxyethyl)-ethylenediamine triace-
tic acid: 3.83 mmol/L |
| | Reagent R2:
p-NPP 80 mmol/L
Sodium azide