(219 days)
Not Found
No
The summary describes a standard automated blood coagulation analyzer and associated reagents and controls. There is no mention of AI, ML, or any advanced algorithms beyond standard photometric analysis and data processing for calculating results and performing quality control. The performance studies focus on traditional analytical and clinical validation metrics.
No
The device is an in vitro diagnostic (IVD) blood coagulation analyzer and reagents, intended for quantitative determination of antithrombin activity in human plasma. It is used for diagnostic purposes in a clinical laboratory setting, not for treating or preventing a disease or condition.
Yes
The CP3000 analyzer is explicitly designed for "in vitro blood coagulation testing" and the accompanying reagents, calibrator, and control set are for "in vitro diagnostic use," which indicates its purpose in diagnosing health conditions.
No
The device description clearly outlines a physical analyzer (CP3000) that uses photometric detection methods with LEDs and a halogen lamp, along with physical reagents, calibrators, and controls. This indicates a hardware component is integral to the device's function.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The intended use and device description for the Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set all explicitly state "For in vitro diagnostic use."
- Intended Use: The CP3000 analyzer is intended for "in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory." The reagents, calibrator, and controls are intended for the "quantitative determination (AT) activity in human 3.2% citrated venous plasma" and for use as calibration and control materials for this assay. These are all activities performed in vitro (outside the body) to diagnose or monitor a medical condition.
- Sample Type: The device analyzes "plasma samples" and "citrated human plasma," which are biological specimens taken from the human body.
- Clinical Laboratory Setting: The intended user and care setting are "healthcare professionals in the clinical laboratory" and "clinical laboratories." IVDs are typically used in these settings.
- Performance Studies: The document describes performance studies including precision, analytical sensitivity, linearity, method comparison with a predicate device, and normal reference range studies. These are standard types of studies performed to validate the performance of IVD devices.
- Predicate Devices: The mention of predicate devices (ACL TOP 700 LAS, HemosIL Liquid Antithrombin, etc.) further indicates that this device is being compared to existing IVD devices on the market.
In summary, the intended use, sample type, setting, and explicit labeling all confirm that the CP3000 analyzer system, including the Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set, is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CP3000 analyzer: The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays.
Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use.
Coagpia Calibrator: The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. - Coagpia AT Reagent
Coagpia Control Set: The Coagpia Control Set contains 2 levels of assayed plasma intended for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use. - Coagpia AT Reagent
Product codes (comma separated list FDA assigned to the subject device)
JPA, JBQ, JIX, GGN
Device Description
CP3000: The CP3000 is designed for easy-to-use, rapid in-vitro blood coagulation testing on citrated human plasma. The CP3000 system is capable of performing the chromogenic methodologic assay, giving the user the ability to perform analysis for both direct hemostasis measurements and calculated parameters. For these assay methodologies, the analyzers employs two photometric detection methods: light scattering and absorbance. The light scattering method uses light emitting diodes at a wavelength of 660 nm, and the absorbance method uses a halogen lamp with filters providing wavelengths at 405/570/730 nm.
Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human plasma on the CP3000 analyzers. The reagent is supplied in a kit of 2 x 10 mL of Reagent 1 and 1 x 10mL of Reagent 2. Both reagents are liquid and do not require any preparation prior to use.
Coagpia Calibrator: The Coagpia Calibrator is supplied as 10 vials of lyophilized human plasma and is suitable for the calibration of the antithrombin activity assay using Coagpia AT Reagent on the CP3000 coagulation analyzers.
Coagpia Control Set: The Coagpia Control Set is supplied as10 vials of lyophilized human plasma; 5 vials of Level 1 Control and 5 vials of Level 2 Control and is suitable for use with the antithrombin activity assay using Coagpia AT Reagent on the CP3000 analyzers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human 3.2% citrated venous plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals in the clinical laboratory. Trained laboratory personnel in clinical laboratories.
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)
Precision (Coagpia AT Reagent):
Study Type: Precision study according to CLSI EP5-A3.
Sample Size: Six samples tested in duplicate, twice per day on 20 non-consecutive days on three CP3000 analyzers using three lots of Coagpia AT Reagent.
Key Results: Repeatability (Within-Run precision), Between-Run precision, Between-day precision, Between Instrument, and Total precision were determined. All results met the criteria (≤10% for Within/Between Run, Between Day, Between Lot, Within Laboratory; ≤15% for Between Instrument and Total CV).
Limit of Quantitation (LOQ):
Study Type: Analytical Sensitivity
Sample Size: Five natural plasmas at concentrations near the lower limit of Reportable Range were measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers for four days, totaling eighty replicates per analyzer.
Key Results: LOQ was determined to be 11% (where the calculated total error estimate falls within the defined goal ≤15%).
Limit of Blank (LOB):
Study Type: Analytical Sensitivity following CLSI Guidance EP17-A.
Sample Size: Five analyte-free plasmas and five natural plasmas at concentrations near the lower limit of Reportable Range were measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers.
Key Results: LOB was determined to be 3%.
Limit of Detection (LOD):
Study Type: Analytical Sensitivity following CLSI Guidance EP17-A.
Sample Size: Five analyte-free plasmas and five natural plasmas at concentrations near the lower limit of Reportable Range were measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers.
Key Results: LOD was determined to be 5%.
Linearity:
Study Type: Linearity study as recommended by CLSI EP6-A.
Sample Size: High AT plasma was diluted with AT deficient plasma to create dilution series. Each sample was measured in quadruplicate using three lots of Coagpia AT Reagent.
Key Results: The data demonstrate a Linear Range of 14 - 140%.
Clinical Reportable Range (CRR):
Study Type: Clinical reportable range study.
Sample Size: High AT plasma was diluted with AT deficient plasma. Each sample was measured in quadruplicate using three lots of Coagpia AT Reagent.
Key Results: The data demonstrate a measurement range up to 179% which met the design goal of 150%. The CRR claim is 14% to 150%.
Analytical Specificity (Endogenous and Exogenous Interference):
Study Type: Interference studies according to CLSI EP7A2.
Key Results: The Coagpia AT Reagent is insensitive to Hemoglobin concentration up to 700mg/dL, Triglyceride concentration up to 2000mg/dL, Unconjugated Bilirubin concentration up to 100mg/dL, Conjugated Bilirubin concentration up to 100mg/dL, α2-Macroglobulin concentration up to 500mg/dL, α1-antitrypsin concentration up to 600mg/dL, Unfractionated heparin concentration up to 8.0IU/mL, Low Molecular Weighted heparin concentration up to 8.0IU/mL, Bivariludin concentration of to 30μg/mL, Dabigatran concentration up to 1000ng/mL, Argatroban concentration up to 2500ng/mL, Rivaroxaban concentration up to 25ng/mL.
Precision (Coagpia Calibrator):
Study Type: Precision studies according to CLSI EP5-A3.
Sample Size: Three lots of Coagpia Calibrator tested in duplicate, twice per day on 20 nonconsecutive days on three CP3000 analyzers using three lots of Coagpia AT Reagent calibrated with in-house primary reference standard.
Key Results: Repeatability (Within-Run precision), Between-Run precision, Between-day precision, Between-lot precision, Within-laboratory precision, and Total precision were determined. All results met the criteria (≤10% for Within/Between Run, Between Day, Between Lot, Within Laboratory; ≤15% for Between Instrument and Total CV).
Precision (Coagpia Control Set):
Study Type: Precision studies according to CLSI EPS-A3.
Sample Size: Three lots of Coagpia Control Set tested in duplicate, twice per day on 20 nonconsecutive days on three CP3000 analyzers using three lots of Coagpia AT Reagent calibrated with in-house primary reference standard.
Key Results: Repeatability (Within-Run precision), Between-Run precision, Between-day precision, Between-lot precision, Within-laboratory precision, and Total precision were determined. All results met the criteria (≤10% for Within/Between Run, Between Day, Between Lot, Within Laboratory; ≤15% for Between Instrument and Total CV).
Method Comparison with Predicate Device:
Study Type: Method comparison study.
Sample Size: A total of 482 samples.
Data Source: Left-over, prospectively collected, citrated plasma samples from three external sites.
Key Results: Results were analyzed using Deming regression. All results met the acceptance criteria: Slope 0.90 to 1.10; Correlation Coefficient (r) ≥ 0.90. Slope = 1.012, Intercept = U.T, R = 0.9909.
Normal Reference Range:
Study Type: Normal reference interval study.
Sample Size: A total of 179 samples.
Data Source: Fresh citrated plasma samples collected from consented, apparently healthy adult volunteers from three external sites.
Key Results: The reference range was established by calculating the non-parametric 95% confidence interval (2.5th to 97.5th percentiles). The mean of the reference range was 108.9% and the central 95% range was 89% to 131%.
Reproducibility:
Study Type: Reproducibility study using a 5x2x3x3 design.
Sample Size: Not explicitly stated as a single number, but mentions five non-consecutive days, two runs per day, three replicates per run at three sites.
Key Results (Coagpia AT Reagent): Three lots of Coagpia AT Reagent were evaluated. For repeatability, the %CV for all six levels ranged from 0.8% to 3.8% (met ≤ 10%). For total reproducibility, the %CV for all six levels ranged from 1.1% to 7.5% (met ≤ 15%).
Key Results (Coagpia Control Set and Coagpia Calibrator): Three lots of Coagpia Control Set and three lots of Coagpia Calibrator were evaluated. For repeatability, the %CV ranged from 0.8% to 3.2% (met ≤ 10%). For total reproducibility, the %CV ranged from 2.7% to 6.1% (met ≤ 15%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (Coagpia AT Reagent):
Repeatability CV: 0.7% - 2.9%
Between Run CV: 0.8% - 5.1%
Between Day CV: 0.0% - 1.9%
Between Lot CV: 0.3% - 1.0%
Within Laboratory CV: 1.1% - 5.8%
Between Instrument CV: 0.6% - 4.8%
Total CV: 1.3% - 7.7%
Analytical Sensitivity:
Limit of Quantitation (LOQ): 11%
Limit of Blank (LOB): 2% - 3%
Limit of Detection (LOD): 4% - 5%
Linearity: 14% - 140%
Clinical Reportable Range (CRR): 14% to 179%. Claimed 14% to 150%.
Precision (Coagpia Calibrator):
Within Run CV: 0.8%
Between Run CV: 1.5%
Between Day CV: 0.0%
Between Lot CV: 2.3%
Within Laboratory CV: 2.8%
Between Instrument CV: 1.5%
Total CV: 3.2%
Precision (Coagpia Control Set):
Level 1 (Mean 99.5): Within Run CV 0.9%, Between Run CV 1.4%, Between Day CV 0.3%, Between Lot CV 1.1%, Within Laboratory CV 2.1%, Between Instrument CV 1.5%, Total CV 2.6%
Level 2 (Mean 31.8): Within Run CV 2.5%, Between Run CV 4.4%, Between Day CV 1.9%, Between Lot CV 2.8%, Within Laboratory CV 6.0%, Between Instrument CV 3.5%, Total CV 6.9%
Method Comparison:
Slope: 1.012
Correlation Coefficient (r): 0.9909
Normal Reference Range: 89% to 131%
Reproducibility (Coagpia AT Reagent):
Within-Run %CV: 0.8% - 3.8%
Total %CV: 1.1% - 7.5%
Reproducibility (Coagpia Control Set and Coagpia Calibrator):
Within-Run %CV: 0.8% - 3.2%
Total %CV: 2.7% - 6.1%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K160276- ACL TOP 700 LAS, K062431, K041905, K021023, K021024
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 9, 2018
Sekisui Medical Co., Ltd. % Shelly Harris Director of Regulatory Affairs Sekisui Diagnostics, LLC 6659 Top Gun Drive San Diego, California 92121
Re: K173202
Trade/Device Name: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA, JBQ, JIX, GGN Dated: March 23, 2018 Received: April 9, 2018
Dear Shelly Harris:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173202
Device Name
CP3000 Coagulation Analyzer, Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set
Indications for Use (Describe)
CP3000 analyzer
The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays.
Coagpia AT Reagent
Coagpia AT Reagent is intended for the quantitative determination (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use.
Coagpia Calibrator
The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. - Coagpia AT Reagent
Coagpia Control Set
The Coagpia Control Set contains 2 levels of assaved plasma intended for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use. - Coagpia AT Reagent
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
SECTION 5 510(K) SUMMARY
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of 21 CFR §807.92. This is a Traditional 510(k).
SPONSOR/APPLICANT INFORMATION AND DATE [807.92(A) (1)] 5.1.
| Owner/Manufacturer Name and Address: | Sekisui Medical Co., Ltd.
1-3, Nihonbashi, 2-Chome
Chuo-ku, Tokyo 103-0027, Japan
FEI Number: 3006769061
Establishment Registration Number: 3003539867 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and Address: | Sekisui Medical Co., Ltd.
1-3, Nihonbashi, 2-Chome
Chuo-ku, Tokyo 103-0027, Japan
FEI Number: 3006769061
Establishment Registration Number: 3003539867 |
| Contact Person: | Shelly Harris
Director of Regulatory Affairs
Sekisui Diagnostics, LLC
(858) 777-2627
Michelle.harris@sekisui-dx.com |
| Application correspondent: | Shelly Harris
Director of Regulatory Affairs
Sekisui Diagnostics, LLC
(858) 777-2627
Michelle.harris@sekisui-dx.com |
Date Summary prepared:
May 3, 2018
4
| Trade Name | Common Name | Classification Name | Classification | Product |
|---|---|---|---|---|
| Code | ||||
| CP3000 | Coagulation | Multipurpose system for in | Class II | JPA |
| Analyzers | vitro coagulation studies | 21 CFR 864.5425 | ||
| Coagpia AT | Antithrombin | Antithrombin III assay | Class II | JBO |
| Reagent | assay reagent | 21 CFR 864.7060 | ||
| Coagpia Calibrator | Calibrator | Calibrator, multi-analyte | Class II | JIX |
| (Standard | mixture | 21 CFR 864.5425 | ||
| Human Plasma) | ||||
| Coagpia Control | Plasma, Coagulation | Class II | GGN | |
| Set | Control Plasma | Control | 21 CFR 864.5425 |
5.2. DEVICE NAME AND CLASSIFICATION [807.92 (A)(2)]
5.3. IDENTIFICATION OF LEGALLY MARKETED PREDICATE DEVICES [807.92(A)(3)]
| Trade Name | Predicate Device | Predicate 510(k) Number |
|---|---|---|
| CP3000 | ACL TOP | K160276- ACL TOP 700 LAS |
| Coagpia AT Reagent | HemosIL Liquid Antithrombin | K062431 |
| Coagpia Calibrator | HemosIL Calibration Plasma | K041905 |
| Coagpia Control Set | HemosIL Normal Control Assayed | |
| HemosIL Low Abnormal Control Assayed | K021023 | |
| K021024 |
5.4. DEVICE DESCRIPTION [807.92 (A)(4)]
| 5.4.
| DEVICE DESCRIPTION 807.92 (A)(4) | |
|---|---|
| Trade Name | Device Description |
| CP3000 | The CP3000 is designed for easy-to-use, rapid in-vitro blood coagulation testing |
| on citrated human plasma. The CP3000 system is capable of performing the | |
| chromogenic methodologic assay, giving the user the ability to perform analysis | |
| for both direct hemostasis measurements and calculated parameters. For these | |
| assay methodologies, the analyzers employs two photometric detection methods: | |
| light scattering and absorbance. The light scattering method uses light emitting | |
| diodes at a wavelength of 660 nm, and the absorbance method uses a halogen lamp | |
| with filters providing wavelengths at 405/570/730 nm. | |
| Coagpia AT | Coagpia AT Reagent is intended for the quantitative determination of antithrombin |
| Reagent | (AT) activity in human plasma on the CP3000 analyzers. The reagent is supplied |
| in a kit of 2 x 10 mL of Reagent 1 and 1 x 10mL of Reagent 2. Both reagents are | |
| liquid and do not require any preparation prior to use. | |
| Coagpia | The Coagpia Calibrator is supplied as 10 vials of lyophilized human plasma and is |
| Calibrator | suitable for the calibration of the antithrombin activity assay using Coagpia AT |
| Reagent on the CP3000 coagulation analyzers. |
5
| Trade Name | Device Description |
|---|---|
| Coagpia Control | |
| Set | The Coagpia Control Set is supplied as10 vials of lyophilized human plasma; 5 vials of Level 1 Control and 5 vials of Level 2 Control and is suitable for use with the antithrombin activity assay using Coagpia AT Reagent on the CP3000 analyzers. |
| Trade Name | Intended Use | |
|---|---|---|
| CP3000 | The CP3000 is a fully automated, random-access in vitro blood coagulation | |
| analyzer intended for use by healthcare professionals in the clinical | ||
| laboratory. The CP3000 analyzer is designed to process plasma samples | ||
| photometrically using chromogenic assays. | ||
| Coagpia AT Reagent | Coagpia AT Reagent is intended for the quantitative determination of | |
| antithrombin (AT) activity in human 3.2% citrated venous plasma. The | ||
| reagent is intended for use on Sekisui CP3000 analyzers by trained | ||
| laboratory personnel in clinical laboratories. For in vitro diagnostic use. | ||
| Coagpia Calibrator | The Coagpia Calibrator is intended for use as a calibration plasma for the | |
| following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained | ||
| laboratory personnel in clinical laboratories. For in vitro diagnostic use. | ||
| Coagpia AT Reagent | ||
| Coagpia Control Set | The Coagpia Control set contains 2 levels of assayed plasma intended for the | |
| quality control of the following Sekisui coagulation assay on Sekisui CP3000 | ||
| analyzers by trained laboratory personnel. For in vitro diagnostic use. | ||
| Coagpia AT Reagent |
INTENDED USE [807.92 (A)(5)] 5.5.
TECHNOLOGICAL SIMILARITIES AND DIFFERENCES TO THE PREDICATE 5.6. [807.92 (A)(6)]
The CP3000 coagulation analyzers and Coagpia AT Reagent, Coagpia Calibrator and Coagpia Control Set included in the submission each has a unique predicate device, as described in the tables below.
5.6.1 CP3000 Coagulation Analyzers
| Characteristic | New Device | Predicate Device |
|---|---|---|
| ---------------- | ------------ | ------------------ |
6
| | CP3000 (CTS and non-CTS)
(There will be 2 catalog codes for
CTS and non-CTS)
(Proposed) | ACL TOP 700 (CTS and non-CTS)
(K160276) |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Options | Available with closed tube sampling
(CTS) function | Same |
| Analytes | Multiple | Same |
| Intended Use and
Indications for Use | The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays. | The ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurement and calculated parameter. |
| Method Types | Chromogenic | Coagulometric (turbidimetric) measurement Chromogenic (absorbance) measurement Immunological measurement |
| Interface | Touch screen operation Windows 7 Operating System | Touch screen operation Windows XP Operating System |
| Detection | Photometric Absorbance Light scattering | Photometric Absorbance |
| Wavelengths | 405 nm 570 nm 660 nm 730 nm | 405 nm 671 nm |
| Throughput
(non-CTS) | Up to 400 clotting tests/hour | Up to 330 PT and APTT tests/hour |
| Reagent Handling | Refrigerated on board Internal bar code sample identification | Same |
|---|---|---|
| ------------------ | --------------------------------------------------------------- | ------ |
5.6.2 Coagpia AT Reagent
| Characteristic | New Device | Predicate Device |
|---|---|---|
| Coagpia AT Reagent | ||
| (Proposed) | HemosIL Liquid Antithrombin | |
| (K062431) | ||
| Analyte | Antithrombin | Same |
| Indications for Use | Coagpia AT Reagent is intended for the | |
| quantitative determination of | ||
| antithrombin (AT) activity in human | ||
| 3.2% citrated venous plasma. The | ||
| reagent is intended for use on Sekisui | ||
| CP3000 analyzers by trained laboratory | ||
| personnel in clinical laboratories. For in | ||
| vitro diagnostic use. | HemosIL Liquid Antithrombin is an | |
| automated chromogenic assay for the | ||
| quantitative determination of | ||
| Antithrombin in human citrated plasma | ||
| as an aid in the diagnosis of hereditary | ||
| and acquired Antithrombin deficiency | ||
| and to monitor Antithrombin | ||
| substitution therapy. |
This in vitro diagnostic test is based on
a synthetic chromogenic substrate and
on Factor Xa inactivation. As a
consequence, it is specific and not
influenced by Heparin Cofactor II.
Antithrombin levels in patient plasma
are measured automatically on IL
Coagulation Systems. |
| Reagent State | Liquid, ready to use | Same |
| Method | Chromogenic | Same |
| Detection | Photometric | Same |
| Key Components | Factor Xa (bovine) Heparin N-Acetyl-D-arginyl-glycyl-L-
arginyl-p-nitroanilide
dihydrochloride (chromogenic
substrate) | Factor Xa (bovine) Heparin N-α-Z-D-Arg-Gly-Arg-
pNA·2HCl (chromogenic
substrate) |
| Sample Type | Human citrated plasma | Human citrated plasma |
| Expected Values | 89 - 131% | 83 - 128% |
| Repeatability | 0.7-2.9% | 2.2 - 7.4% |
| Within Laboratory | 1.1-5.8% | 3.1 - 8.6% |
| Characteristic | New Device | Predicate Device |
| | Coagpia AT Reagent
(Proposed) | HemosIL Liquid Antithrombin
(K062431) |
| Precision | | |
| Clinical Reportable
Range (CRR) | 14-150% | 10 - 150% |
7
8
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5.6.3 Coagpia Calibrator
| Characteristic | New Device | Predicate Device |
|---|---|---|
| Coagpia Calibrator (Proposed) | HemosIL Calibration plasma (K041905) | |
| Intended Use and | ||
| Indications for Use | The Coagpia Calibrator is intended for | |
| use as a calibration plasma for the | ||
| following Sekisui coagulation assay on | ||
| Sekisui CP3000 analyzers by trained | ||
| laboratory personnel in clinical | ||
| laboratories. For in vitro diagnostic | ||
| use. | ||
| Coagpia AT Reagent | HemosIL Calibration plasma is intended | |
| for the calibration of coagulation assays on | ||
| IL and ELECTRA Coagulation Systems. | ||
| Used for the determination of PT, | ||
| Fibrinogen, Single Factors, von Willebrand | ||
| Factor, Antithrombin, Plasminogen, | ||
| Plasmin Inhibitor, Protein C, Protein S, and | ||
| as a reference plasma for APTT and TT. | ||
| Format | Lyophilized | Same |
| Calibrator Type | Antithrombin | Fibrinogen, Antithrombin, PT, Single |
| Factors, von Willebrand Factor, | ||
| Plasminogen, Plasmin Inhibitor, Protein C, | ||
| Protein S, and as a reference plasma for | ||
| APTT and TT. | ||
| Key Components | Human plasma | Same |
5.6.4 Coagpia Control Set
| New Device | Predicate Device | ||
|---|---|---|---|
| Characteristic | Coagpia Control Set | ||
| (Proposed) | HemosIL Normal | ||
| Control Assayed | |||
| (K021023) | HemosIL High Abnormal | ||
| Control Assayed | |||
| (K021024) | |||
| Intended Use and | |||
| Indications for | |||
| Use | The Coagpia Control set | ||
| contains 2 levels of assayed | |||
| plasma intended for the quality | |||
| control of the following | |||
| Sekisui coagulation assay on | |||
| Sekisui CP3000 analyzers by | |||
| trained laboratory personnel. | |||
| For in vitro diagnostic use. | |||
| • Coagpia AT Reagent | HemosIL Normal | ||
| Control ASSAYED is | |||
| intended for the quality | |||
| control of coagulation | |||
| assays in the normal | |||
| range on IL Coagulation | |||
| and ELECTRA Systems. | |||
| The normal control is | |||
| prepared using human | |||
| citrated plasma from | |||
| Health donors. Values | |||
| for all analytes are | HemosIL High Abnormal | ||
| Control ASSAYED is | |||
| intended for the quality | |||
| control of coagulation assays | |||
| in the high abnormal range | |||
| on IL Coagulation and | |||
| ELECTRA Systems. The | |||
| High Abnormal Control is | |||
| prepared using human | |||
| citrated plasma from healthy | |||
| donors (not heparinized | |||
| plasma or plasma samples | |||
| under oral anticoagulation |
10
| | | | within the normal range. therapy) and modified to
stimulate an abnormal
coagulation sample. Values
for all analytes are in the
high abnormal range. |
|----------------|--------------|------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Format | Lyophilized | Same | Same |
| Key Components | Human plasma | Same | Same |
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5.7. SUMMARY OF NON-CLINICAL PERFORMANCE DATA [807.92 (B)(1)] 5.7.1 CP3000 Coagulation analyzers
The CP3000 analyzers were successfully tested for electrical safety, emissions and immunity according to the following standards:
| Description | Standard | Title |
|---|---|---|
| Electrical | ||
| Safety | ||
| Testing | IEC 61010-1 | Safety requirements for electrical equipment for |
| measurement, control and laboratory use. Part 1: General | ||
| requirements | ||
| IEC 61010-2-081 | Safety requirements for electrical equipment for | |
| measurement, control and laboratory use – Part 2-081: | ||
| Particular requirements for automatic and semi-automatic | ||
| laboratory equipment for analysis and other purposes | ||
| IEC 60825-1 | Safety of laser products – Part 1: Equipment classification | |
| and requirements | ||
| IEC61010-2-101 | Safety requirements for electrical equipment for | |
| measurement, control and laboratory use – Part 2-101. | ||
| Particular requirements for in vitro diagnostic (IVD) | ||
| medical equipment | ||
| Emission | IEC 61326-2-6 | Electrical equipment for measurement, control and |
| laboratory use – EMC requirements – Part 2-6: Particular | ||
| requirements – In vitro diagnostic (IVD) medical | ||
| equipment | ||
| CISPR 11 | Industrial, scientific and medical equipment – Radio- | |
| frequency disturbance characteristics – Limits and methods | ||
| of measurement | ||
| IEC 61000-3-2 | Electromagnetic compatibility (EMC) – Part 3-2: Limits – | |
| Limits for harmonic current emissions | ||
| IEC 61000-3-3 | Electromagnetic compatibility (EMC) – Part 3-3: Limits – | |
| Limitation of voltage changes, voltage fluctuations and | ||
| flicker in public low – voltage supply systems, for | ||
| equipment with rated current ≤16 A per phase and not | ||
| Description | Standard | Title |
| subject to conditional connection | ||
| Immunity | IEC 61326-2-6 | Electrical equipment for measurement, control and |
| laboratory use – EMC requirements – Part 2-6: Particular | ||
| requirements – In vitro diagnostic (ICD) medical equipment | ||
| IEC 61000-4-2 | Electromagnetic compatibility (EMC) – Part 4-2: Testing | |
| and measurement techniques – Electrostatic discharge | ||
| immunity test | ||
| IEC 61000-4-3 | Electromagnetic compatibility (EMC) – Part 4-3: Testing | |
| and measurement techniques - Radiated, radio-frequency, | ||
| electromagnetic field immunity test | ||
| IEC 61000-4-4 | Electromagnetic compatibility (EMC) – Part 4-4: Testing | |
| and measurement techniques – Electrical fast transient/burst | ||
| immunity test | ||
| IEC 61000-4-5 | Electromagnetic compatibility (EMC) – Part 4-5: Testing | |
| and measurement techniques – Surge immunity test | ||
| IEC 61000-4-6 | Electromagnetic compatibility (EMC) – Part 4-6: Testing | |
| and measurement techniques - Immunity to conducted | ||
| disturbances, induced by radio-frequency fields | ||
| IEC 61000-4-8 | Electromagnetic compatibility (EMC) – Part 4-8: Testing | |
| and measurement techniques - Power frequency magnetic | ||
| field immunity test | ||
| IEC 61000-4-11 | Electromagnetic compatibility (EMC) – Part 4-11: Testing | |
| and measurement techniques – Voltage dips, short | ||
| interruptions and voltage variations immunity tests |
12
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5.7.2 Coagpia AT Reagent
Precision
Precision studies were performed according to CLSI EP5-A3. Repeatability (Within-Run precision), Between-Run precision, Between-day precision, Between Instrument, and Total precision were determined using six samples tested in duplicate, twice per day on 20 non-consecutive days on three CP3000 analyzers using three lots of Coagpia AT Reagent. The following results were demonstrated:
| Sample | Mean | Repeatability | | Between Run | | Between Day | | Between Lot | | Within
Laboratory | | Between
Instrument | | Total | |
|-----------|-------|---------------|-----------------------------------------|-------------|-----------------------------------------|-------------|-----------------------------------------|-------------|-----------------------------------------|----------------------|-----------------------------------------|-----------------------|-----------------------------------------|-------|-----------------------------------------|
| | | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV | SD | CV |
| Sample 1 | 31.1 | 0.9 | 2.9% | 1.6 | 5.1% | 0.0 | 0.0% | 0.3 | 1.0% | 1.8 | 5.8% | 1.5 | 4.8% | 2.4 | 7.7% |
| Sample 2 | 54.6 | 0.9 | 1.6% | 1.4 | 2.6% | 0.2 | 0.4% | 0.2 | 0.4% | 1.7 | 3.1% | 1.5 | 2.7% | 2.3 | 4.2% |
| Sample 3 | 79.9 | 0.8 | 1.0% | 1.4 | 1.8% | 0.0 | 0.0% | 0.3 | 0.4% | 1.6 | 2.0% | 1.1 | 1.4% | 2.0 | 2.5% |
| Sample 4 | 106.5 | 1.0 | 0.9% | 1.3 | 1.2% | 0.0 | 0.0% | 0.5 | 0.5% | 1.7 | 1.6% | 1.1 | 1.0% | 2.1 | 2.0% |
| Sample 5 | 130.8 | 0.9 | 0.7% | 1.1 | 0.8% | 0.1 | 0.1% | 0.5 | 0.4% | 1.5 | 1.1% | 0.8 | 0.6% | 1.7 | 1.3% |
| Sample 6 | 151.2 | 3.2 | 2.1% | 2.8 | 1.9% | 0.0 | 0.0% | 0.5 | 0.3% | 4.3 | 2.8% | 2.8 | 1.9% | 5.1 | 3.4% |
| Criteria | | | $ \le 10% $ | | $ \le 10% $ | | $ \le 10% $ | | $ \le 10% $ | | $ \le 10% $ | | $ \le 15% $ | | $ \le 15% $ |
| Pass/Fail | | | Pass | | Pass | | Pass | | Pass | | Pass | | Pass | | Pass |
Analytical Sensitivity
Limit of Quantitation:
Limit of Quantitation (LOQ) represents the lowest amount of AT that can be detected reliably. Five natural plasmas at concentrations near the lower limit of Reportable Range were measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers. Measurement has been conducted for four days for a total of eighty replicates per analyzer (5 samples x quadruplicate x 4 days). LOQ was determined at the level where the calculated total error estimate falls within the defined goal (total error ≤15%). The Limit of Quantitation was determined to be 11%.
Limit of Blank:
14
Limit of blank (LOB) is the highest concentration likely to be measured for a blank sample. Five analyte-free plasmas and five natural plasmas at concentrations near the lower limit of Reportable Range were measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers. Results were processed and analyzed following CLSI Guidance EP17-A. The Limit of blank was determined to be 3%.
Limit of Detection:
Limit of detection (LOD) is the lowest concentration of an analyte that is reliably detected. Five analyte-free plasmas and five natural plasmas at concentrations near the lower limit of Reportable Range were measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers. Results were processed and analyzed following CLSI Guidance EP17-A. The Limit of Detection was determined to be 5%.
Linearity:
High AT plasma (pooled plasma) was diluted with AT deficient plasma to create the sample concentration required for this evaluation. The dilution series was prepared above and below the anticipated linear range of the test method as recommended by CLSI EP6-A. Each sample was measured in quadruplicate using three lots of Coagpia AT Reagent. Linearity range was determined at the calculated allowable non linearity estimate falls within the defined goal (allowable non linearity