(276 days)
Not Found
No
The summary describes a standard photometric chemistry analyzer and associated reagents/calibrators/controls. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) chemistry analyzer and associated reagents/calibrators/controls, used for quantitative determination of an enzyme (AST) in human samples to aid in diagnosis, not for treating any condition.
Yes
The "Vital Scientific Selectra Junior Analyzer" is explicitly stated to be for "in vitro diagnostic use" and is used to determine the activity of an enzyme relevant to the diagnosis and treatment of certain diseases.
No
The device description explicitly states it is a "discrete photometric chemistry analyzer" and describes physical reagents and calibrators, indicating it is a hardware-based system with associated consumables, not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use." It also states that the ELITech Clinical Systems AST/GOT 4+1 SL reagent is for "quantitative in vitro diagnostic determination". The calibrator and control serums are also described as being for "in vitro diagnostic use".
- Device Description: The "Device Description" section reiterates that the Vital Scientific Selectra Junior is a "benchtop discrete chemistry photometric analyzer for in vitro diagnostic use."
- Purpose of the Device: The device and its associated reagents, calibrator, and controls are used to measure the activity of the enzyme Aspartate amino transferase in human serum and plasma. This measurement is explicitly stated as being used in the "diagnosis and treatment of certain types of liver and heart disease," which is a diagnostic purpose.
- Use of Biological Samples: The device analyzes human serum and plasma, which are biological samples. This is characteristic of in vitro diagnostics.
Therefore, the text provides multiple clear indications that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use.
ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CIT, JJX, JIT, JJE
Device Description
The reagent device for this submission is available as kit only. It consists of 2 reagents:
Reagent 1 contains Tris buffer, L-Aspartate; Lactate dehydrogenase (LDH) (microorganisms), Malate dehydrogenase (MDH) (bacterial) and sodium azide.
Reagent 2 contains α-Ketoglutarate, NADH and sodium azide
The Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration.
ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels.
Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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)
Method comparison: y=1.016x - 1.86 U/L, R^2= 0.9998, range: 9.5 to 234.4 U/L
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Within run:
Level 21.2 U/L CV=2.3%
Level 46.4 U/L CV=0.8%
Level 203.4 U/LCV=0.5%
Total:
Level 21.2 U/L CV=3.8%
Level 46.4 U/L CV=1.2%
Level 203.4 U/LCV=2.7%
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.
ABX PENTRA AST CP (K060318), Vitalab Flexor (973628), Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (K033501), Roche Diagnostics Precinorm U (K041227), Roche Diagnostics Precipath U (K041227)
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
§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.
(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(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
SEP 20 2010
SECTION 5 - 510(k) Summary - ELITech Clinical Systems AST/GOT 4+1 SL on Vital Scientific Selectra Junior
According to the requirements of 21 CFR 807.92, the following Introduction information provides sufficient detail to understand the basis for a determination of substantial equivalence.
The assigned 510(k) number is : K093883
| Submitter | SEPPIM S.A.S. |
|---|---|
| Address | Zone Industrielle, 61500 SEES, FRANCE |
| Phone number | + 33 (0)2 33 81 21 00 |
| Fax number | + 33 (0)2 33 28 77 51 |
| Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) |
| Date of Preparation | November 27th, 2009 |
Device names
| REAGENT : | | | ELITech Clinical Systems Device
(AST/GOT 4+1 SL) | Predicate device
(ABX PENTRA AST CP) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/proprietary Name: | ELITech Clinical Systems AST/GOT 4+1 SL | Intended use | ELITech Clinical Systems
AST/GOT 4+1 SL reagent is for
the quantitative in vitro diagnostic
determination of the activity of
the enzyme Aspartate amino
transferase in human serum and
plasma on the Vital Scientific
Selectra/Flexor Analyzers.
analyzers for the quantitative in
vitro diagnostic determination of
the enzyme Aspartate amino
transferase (AST) in human
serum and plasma. | For in vitro diagnostic use in the
quantitative determination of
aspartate aminotransferase
(AST) in serum or plasma. |
| Common or Usual Name: | AST-Aspartate amino Transferase, "AST/GOT 4+1 SL" | Indication for Use | Measurement of aspartate amino
transferase levels aids in the
treatment of certain types of liver
and heart diseases. | Measurement of aspartate amino
transferase levels aids in the
treatment of certain types of liver
and heart disease. |
| Device Class | Class II | Assay protocol | Modified IFCC method without
pyridoxal -phosphate | Optimized UV test according to
IFCC modified method without
pyridoxal phosphate. |
| Classification name | Aspartate amino transferase (AST/SGOT) Test system (21 CFR.862.1100) | Composition | Reagent R1:
TRIS pH 7.8, 100 mmol/L; L-
Aspartate 330 mmol/L; MDH ≥ 1000
U/L; LDH ≥ 2000 U/L; Sodium azide
Trade Name: AST/GOT 4+1 SL Regulation Number: 21 CFR §862.1100 Regulation Name: Aspartate aminotransferase (AST/SGOT) Test System Regulatory Class: Class II Product Codes: CIT, JJX, JIT, and JJE Dated: August 30, 2010 Received: September 1, 2010 . .
Dear Ms. Hutson:
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 adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (1 Nr.), It may be bacyed to Title 21, Code of Federal Regulations (CFR), Parts attroching your 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 r lease be aur 1960 that 1271 b isdetermination that your device complies with other not mean that I Dr. has or any Federal statutes and regulations administered by other requirements of the Pro. of al. on al. the Act's requirements, including, but not r ederal agencies: "Fouring (21 CFR Part 807); labeling (21 CFR Parts 801 and minted to: registration and the porting of medical device-related adverse events) (21 607), medical do res reporting (top practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
CJC.
Courtney Harper, 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
K093883 SEP 2 0 2010
Indications for Use Form
510(k) Number (if known): _K093883
Device Name: Vital Scientific Selectra Junior Analyzer (also trademarked as the Flexor Junior Analyzer) AST/GOT 4+1 SL_
Indications for Use:
The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital Scientific Flexor Junior Analyzer) is a discrete photometric chemistry analyzer for in vitro diagnostic use.
ELITech Clinical Systems AST/GOT 4+1 SL reagent is for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate amino transferase in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. Aspartate Amino Transferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093883
10
Indications for Use Form
12093883 SEP 2 0 2010
510(k) Number (if known): _K093883
Device Name:
Indications for Use:
ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
1093883 510(k)________________________________________________________________________________________________________________________________________________________________________
11
Indications for Use Form
510(k) Number (if known): K093883
ELITROL I and ELITROL II_ ____________________________________________________________________________________________________________________________________________________ Device Name:
Indications for Use:
ELITech Clinical Systems ELITROL I is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer.
ELITech Clinical Systems ELITROL II is a single parameter control serum for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.
X 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
WA
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 12093883
16093883