ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL

Q: Who is the manufacturer of ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL?

Seppim S.A.S. filed the 510(k) submission for ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL (K103376).

Q: What is the FDA product code for ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL?

JFY. It is classified under 21 CFR 862.1225 as a Class 2 device in the Clinical Chemistry panel.

Q: What is the regulatory pathway for ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL?

Roche cobas c 111 Creatinine plus ver. 2 (k024098); Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501); Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (k041227).

Q: Who can help prepare an FDA 510(k) submission like ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K103376 · Seppim S.A.S. · JFY · Nov 18, 2011 · Clinical Chemistry

Device Facts

Record ID	K103376
Device Name	ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL
Applicant	Seppim S.A.S.
Product Code	JFY · Clinical Chemistry
Decision Date	Nov 18, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1225
Device Class	Class 2

Intended Use

ELITech Clinical Systems Creatinine PAP SL reagent is for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on the Vital Scientific Selectra/Flexor Analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers. ELITech Clinical Systems ELITROL I is a multi-parametric 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 multi-parametric 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 Story

The ELITech Clinical Systems CREATININE PAP SL is an enzymatic colorimetric assay used for the quantitative determination of creatinine in human serum and plasma. The device consists of two liquid, ready-to-use reagents (R1 and R2) containing enzymes (creatinase, sarcosine oxidase, ascorbate oxidase, creatininase, peroxidase) and buffers. It is designed for use on Vital Scientific Selectra/Flexor analyzers in clinical laboratory settings. The assay operates by converting creatinine into a measurable colorimetric signal proportional to the creatinine concentration in the sample. Healthcare providers use the resulting creatinine measurements to diagnose and treat renal diseases and monitor patients undergoing renal dialysis. The device is intended for professional use only and is not for point-of-care settings.

Clinical Evidence

Bench testing only. Precision studies (n=80 and n=40) showed total CVs 1.6-3.2%. Linearity confirmed 0.28-22.30 mg/dL (r2=0.9999). Method comparison with predicate (n=91) yielded slope 1.045, intercept -0.01. Matrix comparison (serum vs lithium heparin) showed slope 1.013, r=1.000. Interference testing performed per CLSI EP7-A2; positive bias noted with creatine >= 5 mg/dL; negative interference with calcium dobesilate, methyl-dopa, and L-dopa.

Technological Characteristics

Enzymatic colorimetric assay. Reagents: R1 (MOPS buffer, EHSPT, creatinase, sarcosine oxidase, ascorbate oxidase); R2 (MOPS buffer, 4-AAP, creatininase, peroxidase, sodium azide). Liquid, ready-to-use form. Designed for Vital Scientific Selectra/Flexor analyzers. Storage: 2-8 °C, protected from light.

Indications for Use

Indicated for the quantitative determination of creatinine in human serum and plasma for the diagnosis and treatment of renal diseases and monitoring of renal dialysis. Not for Point of Care use.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Predicate Devices

Roche cobas c 111 Creatinine plus ver. 2 (k024098)
Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) (k033501)
Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (k041227)

Related Devices

K132399 — ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL · Elitechgroup · Jan 3, 2014
K193649 — Yumizen C1200 Creatinine PAP · HORIBA ABX SAS · May 10, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ /S2 ### SECTION 5 - 510(k) Summary ELITech Clinical Systems CREATININE PAP SL | 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. | | ELITech Clinical Systems Device CREATININE PAP SL | Predicate device (Roche Diagnostics Creatinine plus ver.2) | |--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The assigned 510(k) number is: K103376 | Intended use | Intended for the quantitative in vitro diagnostic determination of creatinine in human serum or plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. | For in vitro diagnostic use in the quan- titative determination of creatinine in serum, plasma and urine on the cobas c111 system. | | 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 | Indication for Use | Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. | Creatinine measurements are used in the diagnosis and treatment renal diseases, in monitoring renal dialysis and as a calculation basis for measur- ing other urine analytes. | | Contact | Valérie GOURDON (Email: v.gourdon@elitechgroup.com) | Assay protocol | Enzymatic colorimetric test | Enzymatic colorimetric test | | Date of Preparation | November 8th, 2010 | Composition | Reagent R1: MOPS buffer (pH 7.50) EHSPT $0.4 ormal{mmol/L};$ Creatinase $\ge 10 000 ormal{U/L};$ Sarcosine oxidase $\ge 3 250 ormal{U/L};$ Ascorbate oxidase $\ge 1 000 ormal{U/L};$ Reagent R2: | Reagent R1: TAPS buffer $30 ormal{mmol/L};$ Creatinase $\ge 332 \mu ormal{kat/L};$ Sarcosine oxidase $\ge 132 \mu ormal{kat/L};$ Ascorbate oxidase $\ge 33 \mu ormal{kat/L};$ HITB $1.2 ormal{g/L};$ Detergents Preservative | | Device names | | | MOPS buffer (pH 7.50) 4-Aminoantipyrine $2.95 ormal{mmol/L};$ Creatininase $\ge 150 000 ormal{U/L};$ Peroxidase $\ge 4 000 ormal{U/L};$ Sodium azide $< 0.1 \%;$ | Reagent R2: TAPS buffer $50 ormal{mmol/L};$ Creatininase $\ge 498 \mu ormal{kat/L};$ 4-Aminophenazone $0.5 ormal{g/L};$ Peroxidase $\ge 16.6 \mu ormal{kat/L};$ Potassium hexacyanoferrate(II) $60 ormal{mg/L};$ Detergents Preservative | | REAGENT Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems CREATININE PAP SL Creatinine, "CREATININE PAP SL" Class II Creatinine test system (Sec.862.1225) JFY- Enzymatic method, Creatinine | Appearance of re- agents | Liquid form, ready to use | Same | | Predicate device | Roche Diagnostics Creatinine plus ver.2 (K024098) | Sample type | Serum . Plasma | Serum Plasma Urine | | Device description | The device for this submission is available as kit only. It consists of 2 reagents, "R1" and "R2". Reagent R1 contains: MOPS buffer (pH 7.50), EHSPT (N-Ethyl-N-2(- Hydroxy-3-Sulfopropyl)- m -Toluidine), Creatinase (microoganism), Sarcosine oxidase (microoganism), Ascorbate oxidase (vegetal). Reagent R2 contains: MOPS buffer (pH 7.50), Amino-4-antipyrine (4-AAP), Creatininase (bacterial), Peroxidase (horseradish), and Sodium azide. | Reagent storage | Store at 2-8 °C and protect from light. The reagent is stable until the expiry date stated on the label. | Stored at 2-8 °C. Reagents are stable until the expiry date stated on the label. | | Intended Use | ELITech Clinical Systems CREATININE PAP SL is intended for the quantita- tive in vitro diagnostic determination of CREATININE in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. | Expected values | Serum/plasma: Adults : Females 0.55 - 1.02 mg/dL Males 0.72 - 1.18 mg/dL | Serum/plasma: Adults : Females 0.51 - 0.95 mg/dL Males 0.67 - 1.17 mg/dL Children: Neonates(premat.) 0.33-0.98 mg/dL Neonates(full term) 0.31-0.88 mg/dL 2-12 m 0.16-0.39 mg/dL 1-< 3 y 0.18-0.35 mg/dL 3-< 5 y 0.26-0.42 mg/dL 5-< 7 y 0.29-0.47 mg/dL 7-< 9 y 0.34-0.53 mg/dL 9-< 11 y 0.33-0.64 mg/dL | | Indication for use | ELITech Clinical Systems CREATININE PAP SL is intended to measure creatinine in human serum and plasma. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal di- alysis. | | | | {1}------------------------------------------------ #### Comparison to Predicate device {2}------------------------------------------------ | | ELITech Clinical Systems Device CREATININE PAP SL | Predicate device (Roche Diagnostics Creatinine plus ver.2) | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | 13-< 15 y 0.46-0.77 mg/dL | | Instrument | Vital Scientific SELECTRA JUNIOR | Cobas c111 | | Measuring range | 0.28 - 22.30 mg/dL | 0.06 - 30.5 mg/dL | | Limit of detection (LoD) | 0.006 mg/dL | Serum/plasma: 0.06 mg/dL | | Limit of quantification (LoQ) | 0.28 mg/dL | | | Precision | Within run | Serum/plasma: Within run | | | Level 0.59 mg/dL CV=1.3% | Level 0.97 mg/dL CV=2.29% | | | Level 1.62 mg/dL CV=0.8% | Level 3.95 mg/dL CV=1.16% | | | Level 6.93 mg/dL CV=1.4% | Level 0.77 mg/dL CV=2.86% | | | | Level 12.7 mg/dL CV=1.26% | | | Total | Total | | | Level 0.59 mg/dL CV=3.2% | Level 0.97 mg/dL CV=2.35% | | | Level 1.62 mg/dL CV=1.6% | Level 3.95 mg/dL CV=0.91% | | | Level 6.93 mg/dL CV=2.8% | Level 0.75 mg/dL CV=1.87% | | | | Level 13.2 mg/dL CV=0.60% | | Method comparison | $y=1.045x - 0.01 mg/dL$ | Serum/plasma: | | | r= 0.999 | $y=1.006x - 1.11899 µmol/L (0.013 mg/dL)$ | | | range: 0.30 to 20.30 mg/dL | r= 0.9998 | | | | range: 45.9 to 1674 µmol/L (0.52 to 18.9 mg/dL) | | Limitations | Hemoglobin: No significant interfer- ence up to 500 mg/dL. | Hemoglobin: No significant interfer- ence up to an H Index of 800 (approximate 800 mg/dL). | | | Triglycerides: No significant interfer- ence up to 3198 mg/dL . | Lipemia (Intralipid): No significant influence up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration. | | | Unconjugated bilirubin: No signifi- cant interference up to 30.0 mg/dL. | Icterus: No significant influence up to I Index of 20 (approximate conjugated and unconjugated bilirubin concentration of 20 mg/dL (342 µmol/L)). | | | Conjugated bilirubin: No significant interference up 14.8 mg/dL. | Ascorbic acid: < 300 mg/L does not interfere. | | | Uric acid: No significant interference up to 24 mg/dL. | Drugs: No interference was found at therapeutic concentrations using common drug panels. | | | Glucose: No significant interference up to 550 mg/dL. | Exceptions: Levodopa and calcium dobesilate cause artificially low creatinine levels at the tested drug level | | | Ascorbic acid: No significant interfer- ence up to 20 mg/dL. | Other: In very rare cases monoclonal gammopathy can lead to incorrect results. | | | Methyl-dopa: Induce falsely low results at therapeutic concentrations. | No significant interference up to a creatine level of 20 mg/dL. | | | L-dopa: Induce falsely low results at therapeutic concentrations. | | | | Calcium dobesilate: Induce falsely low results at therapeutic concentrations. | | | | Creatine: Positive bias from 5 mg/dL. | | | Calibration Frequency | 14 days | Each lot and as required following quality control procedures. | | | ELITech Clinical Systems Device CREATININE PAP SL | Predicate device (Roche Diagnostics Creatinine plus ver.2) | | On board stability | refrigerated area : 28 days | refrigerated area: 4 weeks | | Calibrator | Recommended calibration material (not included): ELITech Clinical Systems ELICAL 2 | Recommended calibration material (not included): Roche Calibrator f.a.s. | | Controls | Recommended quality control material (not included): ELITech Clinical Systems ELITROL I (Normal control) ELITech Clinical Systems ELITROL II (Pathologic control) | Recommended quality control material (not included): Roche Precinorm U Roche Precipath U | ' {3}------------------------------------------------ #### Device names | CALIBRATOR : | | |-------------------------|-----------------------------------------------| | Trade/proprietary Name: | ELITech Clinical Systems ELICAL 2 | | Common or Usual Name: | Calibrator, multi-analyte mixture, "ELICAL 2" | | Device Class | Class II | | Classification name | Calibrator (21 CFR 862.1150) | | Product code | JIX- Calibrator, multi-analyte mixture | · | 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 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 ac- cording to FDA-approved methods or methods in compliance with the Euro- pean Directive 98/79/EC, Annex II, List A. | | | Intended Use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Sys- tems methods on Vital Scientific Selectra Junior Analyzer and Vital Scientific Flexor Junior Analyzer. | | | | ELITech Clinical Systems Device (ELICAL 2) | Predicate device (Roche Calibrator f.a.s.) | | Intended use | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer and Vital Scientific Flexor Junior Analyzer. | For in vitro diagnostic use in the calibration of quantitative Roche methods on Roche clinical chemis- try analysers as specified in the value sheets. | | Format | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | Lyophilized calibrator based on human serum with constituents added as required to obtain desired components levels | | Level | Single level | Single level | | Handling | Carefully open the vial, avoiding the loss of lyophilate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Carefully open one bottle, avoiding the loss of lyophilate, and pipette in exactly 3 mL of distilled/deionized water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam. | | Traceability | Traceability information is given in the value sheet included in the box. | Traceability of the target value is given in the respective instruction for use of the system reagents. | | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry date After reconstitution, the stabilities are : - 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 expiration date. After reconstitution, the stabilities* are : - 8 hours at 15-25 °C. - 2 days at 2-8 °C. - 4 weeks at (-25)-(-15) °C (when frozen once) *Exception for bilirubin total & direct as noted in package insert | {4}------------------------------------------------ ### Comparison to Predicate device {5}------------------------------------------------ ، #### Device names | CONTROLS: Trade/proprietary Name: Common or Usual Name: Device Class Classification name Product code | ELITech Clinical Systems ELITROL I and ELITROL II Multi-analyte controls - all kinds, "ELITROL I"- "ELITROL II" Class I Quality control material (assayed and unassayed). (21 CFR 862.1660) | |----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | JJY- Multi-analyte controls - all kinds | | 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 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. | | Intended Use | ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer and Vital Scientific Flexor Junior Analyzer. | {6}------------------------------------------------ ### Comparison to Predicate device | | ELITech Clinical Systems Device | Predicate Device | |--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | ELITROL I / ELITROL II | Roche Precinorm U / Precipath U | | Intended use | ELITech Clinical Systems ELITROL I and ELITROL II are multi- parametric control sera for in vitro diagnostic use in accuracy control of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer and Vital Scientific Flexor Junior Analyzer. | For in vitro diagnostic use in quality control by monitoring accuracy and precision for the quantitative meth- ods as specified in the value sheet | | Format | Lyophilized human sera with con- stituents added as required to ob- tain desired components levels | Lyophilized human sera with con- stituents added as required to ob- tain desired components levels | | Levels | Two levels | Two levels | | Handling | Carefully open the vial, avoiding the loss of lyophilate, and pipette in exactly 5 mL of distilled/deionized water. Carefully close the vial and dissolve the contents completely by occasional gentle swirling within 30 minutes avoiding the formation of foam. | Carefully open the bottle, avoiding the loss of lyophilate, and pipette in exactly 5 mL of distilled/deionized water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 30 minutes. Avoid the formation of foam. | | Stability | Lyophilized: To store at 2-8°C and protected from light until the expiry date After reconstitution, the stabilities are : - 12 hours between 15-25 °C. - 5 days between 2-8 °C. - 4 weeks between -25 and -15 °C (when frozen once) | Lyophilized: Stable at 2-8°C up to expiration date. After reconstitution, the stabilities* are : - 12 hours at 15-25 °C. - 5 days at 2-8 °C. - 4 weeks at (-25)-(-15) °C (when frozen once) *Exception for bilirubin total & direct as noted in package insert | #### Conclusion The performance data and other information demonstrate that the safety and effectiveness of these devices versus the predicate devices are not compromised, and that it met all acceptance criteria, demonstrating that the device is substantially equivalent to its respective predicate device. {7}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Seppim S.A.S. C/O Debra Hutson Elitechgroup Epoch Biosciences 21720 23td Dr, SE Suite 150 Bothell, Washington 98021 NOV 1 8 2011 Re: k103376 > Trade Name: Elitech Clinical Systems Creatinne PAP SL Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: JFY, JJY, JIX Dated: October 26, 2011 Received: October 27, 2011 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 affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In 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 not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). {8}------------------------------------------------ Page 2 If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm Sincerely yours, N. Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use Form 510(k) Number (if known): k103376 Device Name: Indications for Use: ELITech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determination of creatinine in human serum and plasma on Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Creatinine measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis. 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) signature Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k103376 Page 1 of 3 {10}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): _k103376 __________________________________________________________________________________________________________________________________________ Device Name: Indications for Use: ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzers. 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) CARS Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)_k103376 {11}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): _k103376 ___________________________________________________________________________________________________________________________________________ ELITech Clinical Systems ELITROL I Device Name: ELITech Clinical Systems ELITROL 11 Indications for Use: ELITech Clinical Systems ELITROL I is a multi-parametric 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 multi-parametric 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. 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) C. A. Z. Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) k103376