Who is the manufacturer of ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

Elitechgroup filed the 510(k) submission for ELITTECH CLINICAL SYSTEMS ALP IFCC SL (K113269).

What is the FDA product code for ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

CJE. It is classified under 21 CFR 862.1050 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

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

Who can help prepare an FDA 510(k) submission like ELITTECH CLINICAL SYSTEMS ALP IFCC SL?

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.

ELITTECH CLINICAL SYSTEMS ALP IFCC SL

K113269 · Elitechgroup · CJE · Dec 29, 2011 · Clinical Chemistry

Device Facts

Record ID	K113269
Device Name	ELITTECH CLINICAL SYSTEMS ALP IFCC SL
Applicant	Elitechgroup
Product Code	CJE · Clinical Chemistry
Decision Date	Dec 29, 2011
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1050
Device Class	Class 2

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.

Device Story

ELITech Clinical Systems ALP IFCC SL is an in vitro diagnostic reagent kit for quantitative determination of alkaline phosphatase in human serum and plasma. The device operates on ELITech Clinical Systems Selectra analyzers using a kinetic colorimetric method based on IFCC recommendations. It measures the rate of p-nitrophenol production at 405 nm. The kit consists of two liquid, ready-to-use reagents: R1 (AMP buffer, magnesium ions, zinc ions) and R2 (p-Nitrophenylphosphate, sodium azide). The assay is performed in clinical laboratory settings by trained personnel. Results assist healthcare providers in diagnosing and monitoring liver, bone, parathyroid, and intestinal diseases. The device is not intended for point-of-care use.

Clinical Evidence

Bench testing only. Performance evaluated via precision (within-run CV 0.6-1.3%, total CV 2.9-4.4%), linearity (18-1005 U/L), and method comparison against the predicate (y= 1.025x - 1, r= 0.998). Interference testing confirmed no significant impact from hemoglobin, triglycerides, bilirubin, ascorbic acid, acetaminophen, or acetylsalicylic acid at specified concentrations.

Technological Characteristics

Kinetic colorimetric assay; measures p-nitrophenol production at 405 nm. Reagents: R1 (AMP buffer pH 10.45, Mg2+, Zn2+), R2 (p-NPP, sodium azide). Liquid, ready-to-use format. Designed for use on Selectra ProM analyzers. Storage: 2-8°C, protected from light. Software-controlled automated analysis on Selectra platform.

Indications for Use

Indicated for the quantitative measurement of alkaline phosphatase or its isoenzymes in human serum and plasma to aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. Not for point-of-care use.

Regulatory Classification

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.

Predicate Devices

Roche Diagnostics ALP2S (Alkaline phosphatase acc. to IFCC Gen.2) (K033185)

Related Devices

K963383 — HICHEM ALP/AMP REAGENT KIT · Hichem Diagnostics · Sep 23, 1996
K033185 — COBAS INTEGRA ALP IFCC GEN.2 · Roche Diagnostics Corp. · Oct 14, 2003
K991387 — ELAN ALKALINE PHOSPHATE REAGENT KIT · Elan Holdings, Inc. · May 19, 1999
K012518 — TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113 · Thermo Dma, Inc. · Oct 9, 2001
K023807 — MODIFICATION TO ALKP · Abbott Laboratories · Dec 26, 2002

Submission Summary (Full Text)

{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 < 0.1% | Reagent R2: p-NPP 132.8 mmol/L Preservatives | | Appearance of reagents | Liquid form, ready to use | Liquid form, ready to use | | Sample type | Serum Plasma | Serum Plasma | | Reagent storage | Store at 2-8 °C and protect from light. The reagent is stable until the expiry date stated on the label. | Store at 2-8 °C the reagent is stable until the expiry date stated on reagent. | | Expected values | Serum/plasma: Men: 20-50 years old: 53-128 U/L ≥ 60 years old: 56-119 U/L Women: 20-50 years old: 42-98 U/L ≥ 60 years old: 53-141 U/L | Serum/plasma: Adults Males (n = 221) 40-129 U/L Females (n = 229) 35-104 U/L Consensus values Males 40-130 U/L Females 35-105 U/L Children aged 1 day &lt250 U/L aged 2-5 days &lt231 U/L aged 6 days-6 months &lt449 U/L aged 7 months-1 year &lt462 U/L aged 1-3 years &lt281 U/L aged 4-6 years &lt269 U/L aged 7-12 years &lt300 U/L aged 13-17 years (f) &lt187 U/L aged 13-17 years (m) &lt390 U/L | - {2}------------------------------------------------ · : . | | ELITech Clinical Systems Device (ALP IFCC SL) | | Predicate device (Roche Diagnostics ALP2S (K033185) | | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | Instrument | Selectra ProM Analyzer | | Cobas c111 | | | Measuring range | 20 - 1023 U/L | | 3 - 1200 U/L | | | Limit of detection (LoD) | 6 U/L | | 3 U/L | | | Limit of quantification (LoQ) | 20 U/L | | | | | Precision | Within run Level 57 U/L Level 144 U/L Level 262 U/L | CV= 1.3% CV= 0.9% CV= 0.6% | Within run Level 87.5 U/L Level 229 U/L Level 43.1 U/L Level 190 U/L | CV= 0.5% CV= 0.7% CV= 0.6% CV= 1.2% | | | Total Level 57 U/L Level 144 U/L Level 262 U/L | CV= 4.4% CV= 3.8% CV= 2.9% | Total Level 90.0 U/L Level 229 U/L Level 53.2 U/L Level 195 U/L | CV= 1.0% CV= 0.8% CV= 0.8% CV= 0.9% | | Method comparison | y= 1.025 x - 1 U/L r= 0.998 range: 18 to 1005 U/L | | y= 1.008 x - 2.207 U/L r= 1.000 range: 32 to 828 U/L | | | Limitations | Hemoglobin: No significant interfer- ence up to 500 mg/dL. Triglycerides: No significant interfer- ence up to 3141 mg/dL Unconjugated bilirubin: No signifi- cant interference up to 30.0 mg/dL (513 µmol/L). Conjugated bilirubin: No significant interference up to 29.5 mg/dL (504 µmol/L). Ascorbic acid: No significant interfer- ence up to 20.0 mg/dL. Acetaminophen: No significant inter- ference up to 30.0 mg/dL. Acetylsalicylic acid: No significant interference up to 200.0 mg/dL. | | Hemoglobin: No significant interfer- ence up to an H Index of 250 (ap- proximate 250 mg/dL). Lipemia (Intralipid): No significant influence up to an L index of 2000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration. Icterus: No significant influence up to I Index of 60 (approximate conju- gated and unconjugated bilirubin con- centration of 60 mg/dL (1026 µmol/L)). | | | Calibration Frequency | 1 day | | 5 days | | | On board stability | 1 day | | 10 days | | | 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, with three faces in profile, suggesting a focus on people and well-being. The seal is simple and professional, reflecting the department's role in public health and human services. 10903 New Hampshire Avenue Silver Spring, MD 20993 ELITechGroup Epoch Biosciences c/o Debra K. Hutson 21720 23rd Dr., SE Suite 150 Bothell, WA 98021 USA DEC 2 9 2011 Re: k113269 Trade Name: ELITech Clinical Systems ALP IFCC SL Regulation Number: 21 CFR §862.1050 Regulation Name: Alkaline Phosphatase or Isoenzymes Test System Regulatory Class: Class II Product Codes: CJE Dated: December 13, 2011 Received: December 22, 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). {4}------------------------------------------------ ## 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/Resourcesfor You/Industry/default.htm Sincerely yours, signature Couriney 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 {5}------------------------------------------------ ## Indications for Use Form 510(k) Number (if known): _ L 32 (36 ELITech Clinical Systems ALP IFCC SL Device Name: 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. 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) Hvanth Division Sign Off Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K113264 Page I of __