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.

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 alpha-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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information for the ELITech Clinical Systems AST/GOT 4+1 SL device:

Device: ELITech Clinical Systems AST/GOT 4+1 SL reagent on Vital Scientific Selectra Junior Analyzer.

1. Table of Acceptance Criteria and Reported Device Performance

This submission focuses on demonstrating substantial equivalence to a predicate device (ABX PENTRA AST CP and Vitalab Flexor). The acceptance criteria are implicitly defined by demonstrating comparable performance to the predicate device within acceptable ranges for clinical diagnostic assays. The table below summarizes the performance metrics reported for the subject device.

Performance Metric	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (ELITech Clinical Systems AST/GOT 4+1 SL)	Comments
Precision	Comparable to predicate	Within-run:- Level 21.2 U/L: CV=2.3%- Level 46.4 U/L: CV=0.8%- Level 203.4 U/L: CV=0.5%	These CVs (Coefficient of Variation) demonstrate good within-run reproducibility.
		Total:- Level 21.2 U/L: CV=3.8%- Level 46.4 U/L: CV=1.2%- Level 203.4 U/L: CV=2.7%	These CVs demonstrate good total precision.
Method Comparison	Strong correlation with predicate (e.g., R² > 0.98, slope ~1, intercept ~0)	$y = 1.016x - 1.86$ U/L$R^2 = 0.9998$Range: 9.5 to 234.4 U/L	Excellent correlation ($R^2=0.9998$) to the predicate method, indicating substantial agreement over the tested range. The slope is very close to 1 and the intercept close to 0.
Measuring Range	Comparable to predicate for clinical utility (Predicate: 3.70 U/L to 600 U/L)	10 to 250 U/L (with automatic post-dilution up to 1800 U/L)	While the initial measuring range is narrower than the predicate, the automatic post-dilution extends it significantly, indicating broader clinical utility or comparable range with dilution.
Calibration Frequency	Clinically acceptable stability (Predicate: 8 days)	28 days	Improved calibration frequency compared to the predicate, indicating better stability.
On-board Stability	Clinically acceptable stability (Predicate: 55 days)	28 days (refrigerated area)	Slightly shorter, but still well within typical clinical laboratory operational periods for on-board reagents.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not explicitly state the specific sample sizes used for the precision and method comparison studies. However, for diagnostic device submissions, "levels" (e.g., Level 21.2 U/L, Level 46.4 U/L, Level 203.4 U/L for precision studies) typically refer to replicates of control materials or pooled patient samples at different concentrations. A method comparison study using a range of 9.5 to 234.4 U/L implies a set of patient samples covering a broad clinical range.

Sample Size for Test Set: Not explicitly stated for each study, but implied to be sufficient for statistical analysis of precision (CVs) and method comparison ($R^2$ and linear regression parameters).
Data Provenance: The submitter is SEPPIM S.A.S. located in France. The studies were likely conducted in a setting compliant with regulatory standards (e.g., GLP/GCP-like principles) for diagnostic device validation. The document does not explicitly state if the samples were retrospective or prospective, nor does it specify the country of origin for the patient samples, but given the manufacturer's location, the data most likely originates from France or other European countries.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The device is a quantitative clinical chemistry assay for AST. For such assays, "ground truth" is typically established by comparing the results of the new device to a legally marketed predicate device or a reference method, rather than through expert consensus on individual results.

The ground truth for the method comparison study was established by the predicate device (ABX PENTRA AST CP) or a method traceable to IFCC formulation.
Number of Experts: Not applicable in the context of establishing ground truth for a quantitative biochemical assay. Experts are involved in setting the performance specifications and interpreting the results, but not in generating the "ground truth" values for the samples themselves in this type of study.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or other diagnostic scenarios where human interpretation is subjective and consensus among experts is needed to establish a definitive "ground truth" diagnosis.

Adjudication Method: Not applicable. For quantitative biochemical assays, the comparison is made directly between the numerical results of the candidate device and the predicate/reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with/without AI

MRMC Study: No, this is not an MRMC comparative effectiveness study. This device is a fully automated in vitro diagnostic (IVD) reagent and analyzer system, not an AI-assisted diagnostic tool requiring human-in-the-loop performance evaluation involving multiple readers.
Effect Size of Human Improvement with/without AI: Not applicable, as there is no human-in-the-loop interaction or AI component discussed for this specific diagnostic device in the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, the performance data presented (precision, method comparison, measuring range, calibration frequency, on-board stability) represents the standalone performance of the ELITech Clinical Systems AST/GOT 4+1 SL reagent when used on the Vital Scientific Selectra Junior Analyzer. It describes the direct analytical capabilities of the system.

7. The Type of Ground Truth Used

Type of Ground Truth: The primary type of ground truth used for performance evaluation (specifically, method comparison) is comparison to a legally marketed predicate device/method (ABX PENTRA AST CP, optimized UV test according to IFCC modified method without pyridoxal phosphate). For precision, it's based on repeated measurements of control materials or pooled samples.

8. The Sample Size for the Training Set

This submission describes a diagnostic reagent and analyzer system, not a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense. The development of such chemical reagents and assay protocols does not involve machine learning training data.

Sample Size for Training Set: Not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for this type of IVD device, this question is not applicable. The development of the reagent assay formulation (Modified IFCC method without pyridoxal-phosphate) is based on established biochemical principles and extensive R&D, rather than machine learning on a dataset with pre-established ground truth.

Summary

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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 SystemsAST/GOT 4+1 SL reagent is forthe quantitative in vitro diagnosticdetermination of the activity ofthe enzyme Aspartate aminotransferase in human serum andplasma on the Vital ScientificSelectra/Flexor Analyzers.analyzers for the quantitative invitro diagnostic determination ofthe enzyme Aspartate aminotransferase (AST) in humanserum and plasma.	For in vitro diagnostic use in thequantitative determination ofaspartate 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 aminotransferase levels aids in thetreatment of certain types of liverand heart diseases.	Measurement of aspartate aminotransferase levels aids in thetreatment of certain types of liverand heart disease.
Device Class	Class II	Assay protocol	Modified IFCC method withoutpyridoxal -phosphate	Optimized UV test according toIFCC modified method withoutpyridoxal 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 ≥ 1000U/L; LDH ≥ 2000 U/L; Sodium azide< 1g/LReagent R2:$\alpha$ -Ketoglutarate 78 mmol/L; NADH1.1 mmol/L; Sodium azide < 1g/L	Reagent R1:TRIS pH 7.8 110 mmol/L; L-Aspartate 340 mmol/L; MDH ≥ 900U/L; LDH ≥ 900 U/L; Sodium azide< 1g/LReagent R2:2-oxoglutarate 85 mmol/L; NADH1.09 mmol/L; Sodium azide < 1g/L
Product code	CIT; NADH oxidation/NAD reduction, Ast/Sgot	Appearance of reagents	Liquid form, ready to use	Liquid form, ready to use
INSTRUMENT:		Traceability/Standardization	IFCC formulation (Schumann,2002), manual measurement	IFCC Reference MeasurementProcedure (37°C) for ASAT
Trade/Proprietary Name:	Vital Scientific Selectra Junior	Sample type	SerumPlasma in lithium heparin	SerumPlasma in lithium heparin
Common or Usual Name:	Clinical analyzer, "Selectra Junior"	Reagent storage	Store at 2-8°C and protectedfrom light. The reagents arestable until the expiry date statedon the label	Reagents, in unopened cassetteare stable up to expiry date orthe label if stored at 2-8°C, andcontamination is avoided.
Device Class:	Class I	Expected values	Serum, Plasma (37°C) :< 40 U/L	Women < 31 U/LMen < 35 U/L37°C
Classification Name:	Discrete Photometric Chemistry Analyzer for Clinical Use (21 CFR 862.2160)	Instrument	Vital Scientific Selectra JuniorAnalyzer (also trademarked asthe Flexor Junior Analyzer)	ABX PENTRA 400
Product Code:	JJE	Measuring range	10 to 250 U/L	3.70 U/L to 600 U/L
Predicate devices	ABX PENTRA AST CP (K060318)Vitalab Flexor (973628)
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 azideThe Vital Scientific Selectra Junior is a benchtop discrete chemistry photometric analyzer for in vitro diagnostic use.

Intended Use

The Vital Scientific Selectra Junior Analyzer (also trademarked as the Vital The Vital Scientific Octooria Vanioi Andiyaret photometric chemistry analyzer for in vitro diagnostic use.

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ELITech Clinical Systems AST/GOT 4+1 SL is intended to measure the Indication(s) for Use enzyme Aspartate amino transferase (AST) in human serum and plasma. Measurements of aspartate amino transferase levels are used in the treatment of certain types of liver and heart diseases.

Comparison to Predicate device

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SEPPIM S.A.S. Zone industrielle 61500 SEES France

		Automatic post-dilution:1800 U/L
Precision	Within run	Within run
	Level 21.2 U/L CV=2.3%	Level 42 U/L CV=2.7%
	Level 46.4 U/L CV=0.8%	Level 123 U/L CV=1.4%
	Level 203.4 U/LCV=0.5%	Level 22 U/L CV=2.3%
	Total	Level 38 U/L CV=2.0%
	Level 21.2 U/L CV=3.8%	Level 145 U/L CV=1.1%
	Level 46.4 U/L CV=1.2%	Total
	Level 203.4 U/LCV=2.7%	Level 42 U/L CV=3.1%
		Level 126 U/L CV=2.5%
		Level 43 U/L CV=3.6%
		Level 348 U/L CV=5.0%
Method comparison	$y=1.016x - 1.86$ U/L	$y=0.99x +1.01$ U/L
	$R^2= 0.9998$	$r^2= 0.9966$
	range: 9.5 to 234.4 U/L	range: 3.70 to 671.80 U/L
Calibration Frequency	28 days	8 days
On board stability	refrigerated area : 28 days	refrigerated area: 55 days

Conclusion

The performance data and other information demonstrate that the safety and effectiveness of this device versus the predicate device is not and choolivenood of this containce criteria, demonstrating that the Compromised, and that it met all accopianos and addition and the substantially

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SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELICAL 2

Introduction	According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for adetermination 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 namesREAGENT
Trade/proprietary Name:	ELITech Clinical Systems ELICAL 2
Common or Usual Name:	Calibrator, secondary, "ELICAL 2"
Device Class	Class II
Classification name	Calibrator (21 CFR 862.1150)
Product code	JIT- Calibrator, secondary
Predicate device	Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
	(K033501)
Device description	ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based onhuman serum containing constituents to ensure optimal calibration.ELICAL 2 is prepared exclusively from the blood of donors tested individuallyand found to be negative for HbsAg and to antibodies to HCV and HIVaccording to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELICAL 2 is a single parameter calibrator for in vitrodiagnostic use in the calibration of quantitative ELITech Clinical Systemsmethods on the Vital Scientific Selectra Junior Analyzer and the Vital ScientificFlexor Junior Analyzer.

. .

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Comparison to Predicate device

	ELITech Clinical Systems Device(ELICAL-2)	Predicate device(Roche Calibrator f.a.s.)
Intended use	ELITech Clinical Systems ELICAL 2is a single parameter calibrator forin vitro diagnostic use in thecalibration of quantitative ELITechClinical Systems methods on theVital Scientific Selectra JuniorAnalyzer and the Vital ScientificFlexor Junior Analyzer.	For in vitro diagnostic use in thecalibration of quantitative Rochemethods on Roche clinicalchemistry analysers as specified inthe value sheets.
Format	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels	Lyophilized calibrator based onhuman serum with constituentsadded as required to obtain desiredcomponents levels
Level	Single level	Single level
Handling	Carefully open the vial, avoiding theloss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the vial anddissolve the contents completely byoccasional gentle swirling within 30minutes avoiding the formation offoam.	Carefully open one bottle, avoidingthe loss of lyophilate, and pipette inexactly 3 mL of distilled/deionizedwater. Carefully close the bottle anddissolve the contents completely byoccasional gentle swirling within 30minutes. Avoid the formation offoam.
Traceability	Traceability information is given inthe value sheet included in the box.	Traceability of the target value isgiven in the respective instructionfor use of the system reagents.
Stability	Lyophilized:To store at 2-8°C and protectedfrom light until the expiry dateAfter reconstitution, the stabilitiesare:- 8 hours between 15-25 °C.- 2 days between 2-8 °C.- 4 weeks between -25 and -15 °C(when frozen once)	Lyophilized:Stable at 2-8°C up to expirationdate.After reconstitution, the stabilitiesare :- 8 hours at 15-25 °C.- 2 days at 2-8 °C.- 4 weeks at (-25)-(-15) °C (whenfrozen once)Exception for bilirubin total & directas noted in package insert

Conclusion

The performance data and other information demonstrate that the safety
The performance data and other the prodicate device is not i he performance uata and other information redicate device is not
and effectiveness of this device versus the predicate demonstrating and effectiveness of this device versus the prodicate do need to that the local that the local that the line the compromised, and that it met all acceptants only as nonel and and

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SECTION 5 - 510(k) Summary - ELITech Clinical Systems ELITROL I and ELITROL II and the control of the control of the control of the contribution of the country of the country of the county of the country of the country of the country of the country of t

Introduction	According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for adetermination of substantial equivalence.
	The assigned 510(k) number is: K093883
SubmitterAddressPhone numberFax 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 27th, 2009
Device names
CONTROLS:Trade/proprietary Name:Common or Usual Name:Device ClassClassification nameProduct code	ELITech Clinical Systems ELITROL I and ELITROL IISingle analyte, Assayed, "ELITROL I"- "ELITROL II"Class IQuality control material (assayed and unassayed). (21 CFR862.1660)JJX- Single (specified) analyte control, (assayed)
Predicate device	Roche Diagnostics Precinorm U (K041227)Roche Diagnostics Precipath U (K041227)
Device description	ELITech Clinical Systems ELITROL I and ELITROL II are two level qualitycontrol products consisting of lyophilized human serum containing constituentsat desired levels.Elitrol I and Elitrol II are prepared exclusively from the blood of donors testedindividually and found to be negative for HbsAg and to antibodies to HCV andHIV according to FDA-approved methods or methods in compliance with theEuropean Directive 98/79/EC, Annex II, List A.
Intended Use	ELITech Clinical Systems ELITROL I is a single parameter control serum for invitro diagnostic use in accuracy control of quantitative ELITech ClinicalSystems methods on the Vital Scientific Selectra Junior Analyzer and the VitalScientific Flexor Junior Analyzer.ELITech Clinical Systems ELITROL II is a single parameter control serum forin vitro diagnostic use in accuracy control of quantitative ELITech Clinical

. . .

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Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

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්‍යය 127 ක් ක්‍රීඩා -

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Public Health Service

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

SEP 2 0 2010

Seppim S.A.S. c/o Debra Hutson ELITech Group Epoch Biosciences 21720 2314 Dr. SE, Suite 150 Bothell, Washington 98021

Re: K093883

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).

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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

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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.

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

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Indications for Use Form

12093883 SEP 2 0 2010

510(k) Number (if known): _K093883

Device Name:

Indications for Use:

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)________________________________________________________________________________________________________________________________________________________________________

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Indications for Use Form

510(k) Number (if known): K093883

ELITROL I and ELITROL II_ ____________________________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

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)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 12093883

16093883

Regulation Number and Section

§ 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.