(15 days)
Not Found
No
The document describes a standard in vitro diagnostic assay for amylase, along with associated calibrators and controls. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies are standard analytical validation studies.
No
The device is an in vitro diagnostic (IVD) product used for the quantitative determination of amylase in human serum and plasma, which aids in the diagnosis and treatment of conditions like pancreatitis. It is not a therapeutic device designed to treat or prevent a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas)," indicating its role in diagnosis.
No
The device description clearly states it is a "kit only" consisting of reagents, calibrators, and control sera, which are physical components, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "intended for the quantitative in vitro determination of amylase in human serum and plasma" and "for in vitro diagnostic use".
- Device Description: Describes reagents, calibrators, and control sera used for testing biological samples (serum and plasma).
- Intended User/Care Setting: Mentions "Prescription Use Only" and "not intended for use in Point of Care settings," which is typical for laboratory-based IVDs.
- Summary of Performance Studies: Details studies like precision, linearity, traceability, stability, interference, and method comparison, all standard performance evaluations for IVD devices.
- Predicate Device(s): Lists predicate devices that are also IVDs (e.g., Roche Diagnostics AMYL2, Calibrator for Automated Systems, Precinorm and Precipath).
The entire context of the document describes a product designed to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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 ELITech Clinical Systems Selectra analyzers.
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 ELITech Clinical Systems Selectra analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JFJ, JIX, JJY
Device Description
ELITech Clinical Systems AMYLASE SL is available as kit only. It consists of one reagent R whose the composition is: MES buffer (pH 6.15), sodium chloride, calcium chloride, potassium thiocyanate, CNP-G3 (2-chloro-4-nitrophenyl-α-maltotrioside), sodium azide.
ELITech Clinical Systems ELICAL2 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 the antibodies to HCV and HIV according to FDA-approved methods.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a 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.
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
Prescription Use Only. It is not intended for use in Point of Care settings.
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)
a. Precision/Reproducibility: The precision of the device was determined in accordance with Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004. Within-run and Total precision results were obtained by performing two runs per day, two measures per run, for 3 levels of samples on 2 instruments during twenty operating days according to CLSI EP5-A2 protocol.
b. Linearity/assay reportable range: The linearity study of AMYLASE SL reagent was performed according to CLSI protocol EP6-A. A measuring range from 20 to 1500 U/L has been determined. Manual dilution 1 to 10 allows an upper linearity of AMYLASE SL reagent to 15000 U/L.
c. Traceability: For calibration, ELITech Clinical Systems ELICAL 2 (manufactured by SEPPIM under product code CALI-0580) must be used. Its value is traceable to the IFCC method.
d. Stability: On board stability for the ELITech Clinical Systems AMYLASE SL was established by real time studies on the ELITech Systems Selectra ProM. The on-board stability of the reagent is 28 days. The shelf-life of AMYLASE SL reagent has been followed in the real time for 24 months on 3 different batches. Control material stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems Elitrol II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C. Calibrator material stability: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C.
e. Detection limit: Determined according to CLSI protocol EP17-A. Limit of Detection (LoD) of AMYLASE SL is 6 U/L. Limit of Quantification (LoQ) of AMYLASE SL is 13 U/L.
f. Interference/analytical specificity: Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, hemoglobin, acetaminophen, ascorbic acid, acetylsalicylic acid were investigated following the recommended sample levels in CLSI EP7-A2 protocol. Concentrations up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides and 500 mg/dL hemoglobin do not show any significant interference. Concentrations up to 30 mg/dL acetaminophen, 20.0 mg/dL ascorbic acid and 200 mg/dL acetylsalicylic acid do not show any significant interference.
g. Method comparison: A correlation study was performed between AMYLASE SL reagent on a Selectra ProM analyzer and Roche Diagnostics AMYL2 (α-Amylase EPS ver.) reagent on a cobas c111 analyzer according to CLSI EP9-A2 protocol. Study used 100 serum patient samples from 21 to 1439 U/L over 5 days. Regression analysis yielded: y = 0.976 x -1 U/L, r = 0.999, r2 = 0.999, Standard error of the estimate Sy.x = 10 U/L.
h. Plasma comparison: 48 paired plasma (in lithium heparin samples, ranging from 22 to 1491 U/L) were tested on Selectra ProM analyzer according to CLSI protocol EP9-A2. Regression analysis yielded: y = 0.907 x + 1 U/L, r = 1.000, r2 = 1.000, Standard error of the estimate Sy.x = 6 U/L.
i. Matrix comparison: Not performed.
j. Expected values/Reference Range:
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.
0
122858
510(k) Summary
ELITech Clinical Systems AMYLASE SL
| 1. Date: | September 14, 2012 |
|---|---|
| 2. Submitter: | ELITech Clinical Systems SEPPIM S.A.S |
| Zone Industrielle | |
| 61500 SEES | |
| FRANCE | |
| 3. Contact Person: | Debra K. Hutson |
| Director, QARA, North America | |
| 21720 23rd Dr SE, Suite 150 | |
| Bothell, WA 98021 | |
| Phone: 425-482-5174 | |
| Fax: 425-482-5550 | |
| Email: d.hutson@elitechgroup.com | |
| 4. Device Description: | ELITech Clinical Systems AMYLASE SL |
| Classification | Class II |
| JFJ | |
| Clinical Chemistry | |
| 21 CFR 862.1070 | |
| Device Description: | ELITech Clinical Systems ELICAL 2 |
| Classification | Class II |
| JIX | |
| Clinical Chemistry | |
| 21 CFR 862.1150 | |
| Device Description: | ELITech Clinical Systems ELITROL I and ELITROL II |
| Classification | Class I, reserved |
| JJY | |
| Clinical Chemistry | |
| 5. Predicate Device: | K063744 |
| Roche Diagnostics | |
| AMYL2 (α-Amylase EPS ver.) | |
| K033501 | |
| Roche Diagnostics | |
| Calibrator for Automated Systems (C.f.a.s.) | |
| K041227 | |
| Roche Diagnostics | |
| Precinorm and Precipath | |
| 6. Intended Use | |
| Reagents: | ELITech Clinical Systems AMYLASE SL is intended for |
| the quantitative in vitro determination of amylase in human | |
| serum and plasma on ELITech Clinical Systems Selectra | |
| analyzers. It is not intended for use in Point of Care | |
| settings. Measurements of amylase are used primarily for | |
| the diagnosis and treatment of pancreatitis (inflammation | |
| of the pancreas). | |
| Calibrators: | ELITech Clinical Systems ELICAL 2 is a multi-parametric |
OCT 3 2012·
.
.
د ب
1
calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Controls:
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 ELITech Clinical Systems Selectra analyzers.
Special conditions for use statement(s):
Prescription Use Only. It is not intended for use in Point of Care settings.
Special instrument requirements:
Performance was provided for the ELITech Clinical Systems Selectra ProM.
Device Description
ELITech Clinical Systems AMYLASE SL is available as kit only. It consists of one reagent R whose the composition is: MES buffer (pH 6.15), sodium chloride, calcium chloride, potassium thiocyanate, CNP-G3 (2-chloro-4-nitrophenyl-α-maltotrioside), sodium azide.
ELITech Clinical Systems ELICAL2 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 the antibodies to HCV and HIV according to FDA-approved methods.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of a 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.
8. Substantial Equivalence Information -
Assay
-
- Predicate Device Name
- Roche Diagnostics AMYL2 (a-Amylase EPS ver.)
-
- Comparison with predicate
Similarities
| Parameter | AMYLASE SL | Roche Diagnostics AMYL2
(α-Amylase EPS ver.) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for the quantitative
in vitro determination of
amylase 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 determination of
amylase in human serum and
plasma on the cobas c111
system. |
| Specimen Type | Serum, Plasma | Same |
| Assay Technology | Enzymatic method | Same |
| Calibration frequency | 28 days | Same |
2
Differences
| Parameter | AMYLASE SL | Roche Diagnostics AMYL2
(α-Amylase EPS ver.) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Range | Serum/plasma:20 - 1500 U/L | Serum/plasma: 3-1500 U/L |
| Instrument | Selectra ProM analyzer | cobas c111 |
| Calibrator | Recommended calibration
material (not included):
ELITech Clinical Systems
ELICAL 2 | Recommended calibration
material (not included):
Roche Calibrator f.a.s. |
| Interference | Triglycerides: No significant
interference up to 3000
mg/dL.
Unconjugated bilirubin: No
significant 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
interference up to 20.0
mg/dL.
Acetaminophen: No
significant interference up to
30.0 mg/dL.
Acetylsalicylic acid: No
significant interference up to
200.0 mg/dL. | Hemoglobin: No significant
interference up to an H Index
of 100 (approximate 100
mg/dL).
Lipemia (Intralipid): No
significant influence up to an
L index of 1000. Icterus: No
significant influence up to I
Index of 15 (approximate
conjugated and unconjugated
bilirubin concentration of 15
mg/dL (257µmol/L)). |
| Reference Range | Serum/plasma:11 Schumann, G., et al., IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37°C, Clin Chem Lab Med, (2006), 44(9), 1146.
3
Control Sera
-
- Predicate Device Name:
- Roche Diagnostics Precinorm U and Precipath U
.
-
- Comparison with predicate
| Similarities and Differences | ||
|---|---|---|
| Item | Candidate Device | |
| (ELITech Clinical Systems | ||
| ELITROL I and ELITROLII) | Predicate | |
| Roche Diagnostics | ||
| Precinorm U and Precipath U | ||
| (K041227) | ||
| Intended Use/Indications for | ||
| Use | ELITech Clinical Systems | |
| ELITROL I and ELITROL II | ||
| are multi-parametric control | ||
| sera for in vitro diagnostic | ||
| use in quality control of | ||
| quantitative ELITech | ||
| Clinical Systems methods on | ||
| ELITech Clinical Systems | ||
| Selectra Analyzers. | Precinorm U is for use in quality | |
| control by monitoring accuracy | ||
| and precision for the quantitative | ||
| methods as specified in the | ||
| value sheets. | ||
| Precipath U is for use in | ||
| quality control by monitoring | ||
| accuracy and precision for | ||
| the quantitative methods as | ||
| specified in the value sheets. | ||
| Format | Lyophilized human sera with | |
| constituents added as | ||
| required to obtain defined | ||
| component levels | Same | |
| Levels | Two Levels (Level I and | |
| Level II) | Same | |
| Stability | Lyophilized: Store at 2-8°C | |
| and protected from light until | ||
| the expiry date. After | ||
| Reconstitution: 12 hours | ||
| between 15-25°C, 5 days | ||
| between 2-8°C, 4 weeks | ||
| between -25 and -15°C | ||
| (when frozen once) | Same |
Calibrator
-
- Predicate Device Name:
- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s)
- Comparison with predicate
| Similarities and Differences | ||
|---|---|---|
| Item | Candidate Device | |
| (ELITech Clinical Systems | ||
| ELICAL 2) | Predicate | |
| Roche Calibrator for | ||
| Automated Systems (C.f.a.s.) | ||
| K033501 | ||
| Intended Use/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 ELITech Clinical | ||
| Systems Selectra analyzers. | Calibrator for automated systems | |
| (C.f.a.s.) is for use in the | ||
| calibration | ||
| of quantitative Roche methods | ||
| on Roche clinical chemistry | ||
| analyzers | ||
| as specified in the value sheets. |
.
4
| Format | Lyophilized calibrator based
on human serum with
constituents added as
requires to obtain desired
component levels | Same |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Level | Single Level | Same |
| Stability | Lyophilized: store at 2-8°C
and protect from light until the
expiry date.
After reconstitution: 8 hours
between 15-25°C, 2 days
between 2-8°C, 4 weeks
between -25 and -15°C
(when frozen once) | Same |
റ്റ. Standard/Guidance Document Reference
- Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.
- Protocols for Determination of Limits of Detection and Limits of Quantification; . Approved Guideline. CLSI (NCCLS) document EP17-A, vol 24, No. 34, October 2004.
- Method Comparison and Bias estimation Using Patient Samples; Approved . Guideline-Second Edition. CLSI (NCCLS) document EP9-A2-IR, Vol 30, No. 17, July 2010.
- Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices . Intended for Professional Use: Guidance for Industry and FDA Staff, November 2004.
- Interference Testing in Clinical Chemistry; Approved Guideline-Second . Edition. CLSI (NCCLS) document EP07-A2, Vol 25, No. 27, November 2005.
- Evaluation of the Linearity of the Measurement of Quantitative Procedures: a . Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP6-A, Vol 23, No. 16, April 2003.
10. Test Principle:
Enzymatic Method. Substrate CNP-G3 is hydrolyzed by catalitic action of a-amylase to produce CNP (2chloro-4-nitrophenol).
5 CNP-G3 &amylase 3CNP + 2CNP-G2 + 3 Maltotriose + 2 Glucose
CNP-G2 = 2-Chloro-4-nitrophenyl-a-maltoside
The rate of increase in absorbance is measured at 405 nm and is directly proportional to the activity «-amylase in the sample.
5
Performance Characteristics - Analytical Performance 11.
a. Precision/Reproducibility
The precision of the device was determined in accordance with Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.
Within-run and Total precision results were obtained by performing two runs per day. two measures per run, for 3 levels of samples on 2 instruments during twenty operating days according to CLSI EP5-A2 protocol. The results are presented in the table below:
| n | Mean (U/L) | Within-run SD | Within-run CV% | |
|---|---|---|---|---|
| Level 1 | 80 | 82 | 1.07 | 1.3 |
| Level 2 | 80 | 204 | 1.81 | 0.9 |
| Level 3 | 80 | 992 | 14.50 | 1.5 |
Within-Run Precision
Total Precision
| n | Mean (U/L) | Total SD | Total CV% | |
|---|---|---|---|---|
| Level 1 | 80 | 82 | 2.21 | 2.7 |
| Level 2 | 80 | 204 | 4.40 | 2.2 |
| Level 3 | 80 | 992 | 25.36 | 2.6 |
b. Linearity/assay reportable range
The linearity study of AMYLASE SL reagent was performed according to CLSI protocol EP6-A. From this study, a measuring range from 20 to 1500 U/L has been determined. Manual dilution 1 to 10 allows an upper linearity of AMYLASE SL reagent to 15000 U/L.
c. Traceability
For calibration, a multi-parametric calibrator named ELITech Clinical Systems ELICAL 2 (manufactured by SEPPIM under product code CALI-0580) must be used. Its value is traceable to the IFCC method.
d. Stability
Real-time stabilities:
On board stability for the ELITech Clinical Systems AMYLASE SL was established by real time studies on the ELITech Systems Selectra ProM. The on-board stability of the reagent is 28 days. The shelf-life of AMYLASE SL reagent has been followed in the real time for 24 months on 3 different batches.
6
Control material is purchased from a commercial vendor (previously cleared under K041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems Elitrol II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.
Calibrator material is purchased from a commercial vendor (previously cleared under K033501). The following is claimed for stability: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling stated that the Elical 2 should be stored tightly capped and protected from light when not in use.
Value Assignment
Elitrol I and II are value assigned using multiple Vital Scientific Pro M analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
Elical 2 is tested against predetermined values on multiple Vital Scientific Pro M using the AMYLASE SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.
e. Detection limit
Determined according to CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
Limit of Detection (LoD) of AMYLASE SL obtained from 15 measurements of 4 samples with a low concentration of analyte (approximately 4 x LoB ~ 13 U/L) is 6 U/L.
Limit of Quantification (LoQ) of AMYLASE SL obtained from 15 measurements of 4 samples at nominal concentration 13 U/L is 13 U/L.
f. Interference/analytical specificity
Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, hemoglobin, acetaminophen, ascorbic acid, acety|salicylic acid were investigated following the recommended sample levels in CLSI EP7-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). The results of testing interferences are the following:
- Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides and 500 mg/dL hemoglobin do not show any significant interference for each substance.
- Likewise, concentrations up to 30 mg/dL acetaminophen, 20.0 mg/dL ascorbic acid । and 200 mg/dL acetylsalicylic acid do not show any significant interference for each substance.
The following statement will also be included in the labeling:
Other compounds may interfere. Users should refer to the two following literature references:
-Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 Ed., AACC Press, (1997).
-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2
7
case reports and a review of literature, Acta Clin Belg, (2004), 59, 263.
Performance Characteristics - Comparison Studies 12.
a. Method comparison
.
A correlation study was performed between AMYLASE SL reagent on a Selectra ProM analyzer and Roche Diagnostics AMYL2 (α-Amylase EPS ver.) reagent on a cobas c111 analyzer according to CLSI EP9-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
This study was performed using 100 serum patient samples from 21 to 1439 U/L over a span of 5 days.
Regression analysis of the results yielded the following:
y = 0.976 x -1 U/L r = 0.999 r2 = 0.999 Standard error of the estimate Sy.x = 10 U/L.
b. Comparison study: Plasma comparison
48 paired plasma (in lithium heparin samples, ranging from 22 to 1491 U/L, were tested on Selectra ProM analyzer according to CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition). Regression analysis of the results yielded the following:
v = 0.907 x + 1 U/L r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 6 U/L.
c. Matrix comparison:
Matrix comparison studies were not performed. See serum and plasma method comparison data above (Section 12 a. & b.)
We claim that lithium heparin plasma is an acceptable anticoagulant.
d. Expected values/Reference Range
As indicated in the instructions for use for AMYLASE SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.
Trade Name: ELITech Clinical Systems AMYLASE SL; ELITech Clinical Systems ELICAL 2; ELITech Clinical Systems ELITROL I and ELITROL II Regulation Number: 21 CFR §862.1070 Regulation Name: Amylase test system. Regulatory Class: Class II Product Codes: JFJ, JIX and JJY Dated: September 14, 2012 Received: September 18, 2012
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).
3 2012
9
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 Devices and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" And, product not regarding regarding postmarket surveillance, please contact CDRH'S Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-576-. 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 Tou may 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,
Ci
Courtney H. Lias, Ph.D Director Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
Indications for Use Form
510(k) Number (if known):
ELITech Clinical Systems AMYLASE SL Device Name:
Indications for Use:
ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
It is not intended for use in Point of Care settings.
Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).
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)
Yung Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122858
Page 1 of 3
11
Indications for Use Form
510(k) Number (if known): K122858
ELITech Clinical Systems ELICAL 2 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 on ELITech Clinical Systems Selectra 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)
Yung Chan
Division Sign-(0) Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122858
Page 2 of 3
12
Indications for Use Form
510(k) Number (if known): K122858
Device Name:
ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II
Indications for Use:
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
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)
Yung Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K122858
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