(228 days)
Not Found
No
The description details a standard chemiluminescent immunoassay and automated analyzer system. There is no mention of AI or ML in the intended use, device description, or performance studies. The analyzer software performs standard calculations based on the measured light signal.
No
Explanation: This device is an in vitro diagnostic (IVD) assay designed to measure fecal calprotectin for diagnostic purposes, not to treat or alleviate a disease or condition.
Yes
The DiaSorin LIAISON® Calprotectin assay is described as an "in vitro diagnostic chemiluminescent immunoassay" and is "intended for the quantitative measurement, in human stool, of fecal calprotectin..." which "can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD)..." This clearly indicates its purpose is diagnostic. The LIAISON® Q.S.E.T. Device Plus is used in the preparation of specimens for this diagnostic assay.
No
The device is an in vitro diagnostic assay that requires specific hardware (LIAISON® Analyzer Family, LIAISON® Q.S.E.T. Device Plus) to perform the test and generate results. While software is used for calculation, it is integral to a hardware-based system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA)..."
- Purpose: The device is intended for the quantitative measurement of fecal calprotectin in human stool, which is a biological sample taken from the body.
- Diagnostic Aid: The assay is used as an aid in the diagnosis of inflammatory bowel diseases (IBD) and in differentiating IBD from irritable bowel syndrome (IBS). This indicates its use in a diagnostic context.
- Laboratory Use: The test is performed on the LIAISON® Analyzer Family, which are automated systems typically found in clinical laboratories.
- Sample Preparation: The LIAISON® Q.S.E.T. Device Plus is specifically intended for the preparation of human stool specimens for testing in the LIAISON® Calprotectin assay, further reinforcing its role in an in vitro diagnostic process.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA) intended for the quantitative measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The LIAISON® Calprotectin assay can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome (IBS). Test results are to be used in conjunction with information obtained from the patients' clinical evaluation and other diagnostic procedures.
The test has to be performed on the LIAISON® Analyzer Family.
The DiaSorin LIAISON® Q.S.E.T. Device Plus (Quantitative Stool Extraction and Test) is intended for use in the preparation of human stool specimens for testing in the LIAISON® Calprotectin assay.
Product codes
NXO
Device Description
The LIAISON® Calprotectin assay is a sandwich assay that uses 2 monoclonal antibodies for capture and detection of calprotectin. The LIAISON® Calprotectin assay must be run on the LIAISON® Analyzer family, a fully automated system with continuous loading.
Calprotectin is first extracted from human stool samples with LIAISON® Q.S.E.T. Buffer using either the weigh method, the LIAISON® Q.S.E.T. Device or the LIAISON® Q.S.E.T. Device Plus. The assay incubates extracted sample, calibrator, control, or calibration verifiers with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the calprotectin heterocomplex. Following incubation, a wash cycle is performed to remove any unbound material. An isoluminol conjuqated monoclonal antibody that recognizes calprotectin is then added to the reaction and incubated. The unbound conjugate is removed with a second wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of calprotectin present in the calibrators, controls or samples.
All assay steps and incubations are performed by the LIAISON® XL Analyzer. The analyzer software automatically calculates the concentration of calprotectin in the sample. This concentration is expressed in uq/q.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human stool
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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/REPRODUCIBILITY:
LIAISON® Q.S.E.T. DEVICE PLUS EXTRACTION REPRODUCIBILITY
LIAISON® Q.S.E.T. Device Plus extraction reproducibility was tested using five (5) stool samples spanning the analytical measuring range of the assay. Samples were extracted using the LIAISON® Q.S.E.T. Device Plus and tested once (1) per day using six (6) replicates over five (5) days by three (3) operators, for a total of 90 measurements per sample. Each LIAISON® Q.S.E.T. Device Plus extraction was performed daily by each operator independently. CLSI document EP15-A3 was consulted in the preparation of the testing protocol.
Reproducibility
LIAISON® Q.S.E.T. Device Plus sampling reproducibility was tested using 5 human stool specimens ranging from 2 – 7 on the Bristol Stool Form Scale (BSFS) which were sampled by 3 operators with 5 replicates per specimen per operator on 3 lots of devices for a total of 225 sampling events. The weight of each sample collected by the Q.S.E.T. Device Plus was determined by comparison against the empty device. Repeatability was assessed across all 5 specimens, replicates, operators, and lots.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5180 Fecal calprotectin immunological test system.
(a)
Identification. A fecal calprotectin immunological test system is anin vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.(b)
Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2022
DiaSorin Inc. Christa Blaisdell Senior Regulatory Specialist 1951 Northwestern Ave Stillwater, Minnesota 55082
Re: K213858
Trade/Device Name: LIAISON Calprotectin, LIAISON O.S.E.T. Device Plus Regulation Number: 21 CFR 866.5180 Regulation Name: Fecal Calprotectin Immunological Test System Regulatory Class: Class II Product Code: NXO Dated: December 9, 2021 Received: December 10, 2021
Dear Christa Blaisdell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213858
Device Name LIAISON® Calprotectin LIAISON® Q.S.E.T. Device Plus
Indications for Use (Describe)
The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA) intended for the quantitative measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The LIAISON® Calprotectin assay can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome (IBS). Test results are to be used in conjunction with information obtained from the patients' clinical evaluation and other diagnostic procedures.
The test has to be performed on the LIAISON® Analyzer Family.
The DiaSorin LIAISON® Q.S.E.T. Device Plus (Quantitative Stool Extraction and Test) is intended for use in the preparation of human stool specimens for testing in the LIAISON® Calprotectin assay.
| 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
510(k) SUMMARY
| SUBMITTED BY: | Christa Blaisdell
Senior Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285
Phone (651) 351-5866
Fax (651) 351-5669
Email: christa.blaisdell@diasorin.com |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | July 25, 2022 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® Calprotectin
LIAISON® Q.S.E.T. Device Plus |
| Common Names/Descriptions: | Calprotectin assay |
| Classification Names: | Fecal calprotectin immunological test system:
Class II, 21 CFR: 866.5180; Immunology (82) |
| Product Code: | NXO |
| PREDICATE DEVICES : | LIAISON® Calprotectin, LIAISON® Q.S.E.T. Device
(K182698) |
DEVICE DESCRIPTION:
INTENDED USE:
The DiaSorin LIAISON® Calprotectin assay is an in vitro diagnostic chemiluminescent immunoassay (CLIA) intended for the quantitative measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The LIAISON® Calprotectin assay can be used as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome (IBS). Test results are to be used in conjunction with information obtained from the patients' clinical evaluation and other diagnostic procedures.
The test has to be performed on the LIAISON® Analyzer family.
The DiaSorin LIAISON® Q.S.E.T. Device Plus (Quantitative Stool Extraction and Test) is intended for use in the preparation of human stool specimens for testing in the LIAISON® Calprotectin assay.
INDICATIONS FOR USE Same as intended use.
4
KIT DESCRIPTION:
The LIAISON® Calprotectin assay is a sandwich assay that uses 2 monoclonal antibodies for capture and detection of calprotectin. The LIAISON® Calprotectin assay must be run on the LIAISON® Analyzer family, a fully automated system with continuous loading.
Calprotectin is first extracted from human stool samples with LIAISON® Q.S.E.T. Buffer using either the weigh method, the LIAISON® Q.S.E.T. Device or the LIAISON® Q.S.E.T. Device Plus. The assay incubates extracted sample, calibrator, control, or calibration verifiers with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the calprotectin heterocomplex. Following incubation, a wash cycle is performed to remove any unbound material. An isoluminol conjuqated monoclonal antibody that recognizes calprotectin is then added to the reaction and incubated. The unbound conjugate is removed with a second wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of calprotectin present in the calibrators, controls or samples.
All assay steps and incubations are performed by the LIAISON® XL Analyzer. The analyzer software automatically calculates the concentration of calprotectin in the sample. This concentration is expressed in uq/q.
COMPARISON WITH PREDICATE
The LIAISON® Calprotectin assay is the same as cleared for the market by K182968, with additional specimen stability claims included within the Instructions for Use.
The Q.S.E.T. Device Plus differs from its predicate Q.S.E.T. Device in that it is provided ready to use, and comes prefilled with the same extract buffer as required for use with the Q.S.E.T. Device, eliminating the need for the user to prepare the buffer and add it to the device themselves. In addition, minor changes to the shape and design of the tube were made.
A comparison of the similarities and differences between the devices are provided in the following tables.
5
| Characteristic | Predicate Device
LIAISON® Calprotectin (K182698
cleared 12/26/2018) | Updated Device
LIAISON® Calprotectin |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/Indications for
Use | The DiaSorin LIAISON®
Calprotectin assay is an in vitro
diagnostic chemiluminescent
immunoassay (CLIA) intended for
the quantitative measurement, in
human stool, of fecal calprotectin,
a neutrophilic protein that is a
marker of mucosal inflammation.
The LIAISON® Calprotectin assay
can be used as an aid in the
diagnosis of inflammatory bowel
diseases (IBD), specifically
Crohn's disease and ulcerative
colitis, and as an aid in
differentiation of IBD from irritable
bowel syndrome (IBS). Test
results are to be used in
conjunction with information
obtained from the patients' clinical
evaluation and other diagnostic
procedures.
The test has to be performed on
the LIAISON® XL Analyzer.
The DiaSorin LIAISON® Q.S.E.T.
Device (Quantitative Stool
Extraction and Test) is intended
for use in the preparation
of human stool specimens for
testing in the LIAISON®
Calprotectin assay. | The DiaSorin LIAISON®
Calprotectin assay is an in vitro
diagnostic chemiluminescent
immunoassay (CLIA) intended for
the quantitative measurement, in
human stool, of fecal calprotectin,
a neutrophilic protein that is a
marker of mucosal inflammation.
The LIAISON® Calprotectin assay
can be used as an aid in the
diagnosis of inflammatory bowel
diseases (IBD), specifically
Crohn's disease and ulcerative
colitis, and as an aid in
differentiation of IBD from irritable
bowel syndrome (IBS). Test
results are to be used in
conjunction with information
obtained from the patients' clinical
evaluation and other diagnostic
procedures.
The test has to be performed on
the LIAISON® Analyzer Family.
The DiaSorin LIAISON® Q.S.E.T.
Device Plus (Quantitative Stool
Extraction and Test) is intended
for use in the preparation
of human stool specimens for
testing in the LIAISON®
Calprotectin assay. |
| Principles of operation | Sandwich assay that uses 2
monoclonal antibodies for capture
and detection of calprotectin | Same |
| Materials provided | Magnetic particles (2.4 mL)
Conjugate (25.0 mL)
Assay Buffer (27.0 mL)
Specimen Diluent (13.0 mL)
Number of tests: 100
Calibrator 1 (2 x 1.0 mL)
Calibrator 2 (2 x 1.0 mL) | Same |
| Optional Laboratory Supplies | LIAISON® Q.S.E.T. Device
(REF 319050) | LIAISON® Q.S.E.T. Device
(REF 319050)
LIAISON® Q.S.E.T. Device Plus
(REF 319060) |
| Reagent stability
(unopened, 2-8°C) | Up to the expiration date | Same |
| Reagent stability
(opened, 2-8°C) | Upright or on board the Analyzer
for 56 days | Same |
| Table 1: Comparison of the LIAISON® Calprotectin assay to the predicate device | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -------------------------------------------------------------------------------- | -- | -- | -- | -- |
6
| Characteristic | Predicate Device
LIAISON® Calprotectin (K182698
cleared 12/26/2018) | Updated Device
LIAISON® Calprotectin |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------|-------------------------------------------|
| Calibrator stability
(Room temperature) | 6 hours | Same |
| Calibrator stability
(2-8°C) | 28 days | Same |
| Specimen storage stability
(Room temperature) | No value provided | Stable up to 6 hours |
| Specimen storage stability
(2-8°C) | 72 hours | Same |
| Specimen storage stability
(-20°C) | Store frozen at -20°C or below. | Stable up to 16 weeks frozen at -
20°C |
| Specimen extract storage
stability
(Room temperature, 18-
25°C) | 4 hours | Same |
| Specimen extract storage
stability
(2-8°C) | 6 hours | Same |
| Specimen extract storage
stability
(-20°C) | No value provided | Stable 7 days |
| Specimen extract storage
stability
(Freeze/thaw cycle) | No value provided | Stable through 1 freeze/thaw
cycle |
| Partial Specimen extract
storage stability
(Room temperature) | NA | Stable 8 hours |
| Partial Specimen extract
storage stability
(2-8°C) | NA | Stable 7 days |
7
| Characteristic | Predicate Device
LIAISON® Q.S.E.T. Device
(K182698 cleared 12/26/2018) | Updated Device
LIAISON® Q.S.E.T. Device Plus |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Intended use | The DiaSorin LIAISON® Q.S.E.T.
Device Plus (Quantitative Stool
Extraction and Test) is intended
for use in the preparation of
human stool specimens for testing
in the LIAISON® Calprotectin
and/or LIAISON® Elastase-1
assays. | Same |
| Physical attributes | Flat bottom tube with cap | Round bottom tube (longer and
wider) |
| | 2 caps: 1 for tube, 1 cap includes
sampling wand and funnel | 1 cap includes sample wand and
funnel |
| | Sampling wand | Wand length is longer to
accommodate larger tube |
| | Funnel to remove excess stool | Same |
| | Material: polypropylene | Same |
| Average volume of sample
collected | 11.8 mg | 11.3 mg |
| Materials provided | Polypropylene mixing tube with
black funnel, screw cap, and white
sampling wand with blue cap. | Polypropylene mixing tube with
black funnel, screw cap, and white
sampling wand with blue cap. The
tube contains 6.0 mL of Q.S.E.T.
Buffer, a buffered solution
containing BSA, surfactant, 0.1%
ProClin®300 and 0.05%
gentamicin sulfate. |
| Number of Tests | 100 devices. Each device is for 1
time use
Provided separately, not included
with kit | Same |
| Method | LIAISON® Q.S.E.T. Buffer is
provided separately. User must
prepare buffer and add to device. | Device is pre-filled with LIAISON®
Q.S.E.T. Buffer. Ready to Use. |
| Storage | Room temperature | 2-8°C |
Table 2: Comparison of the LIAISON® Q.S.E.T. Device Plus to the predicate device
8
PERFORMANCE DATA:
PRECISION/REPRODUCIBILITY:
LIAISON® Q.S.E.T. DEVICE PLUS EXTRACTION REPRODUCIBILITY
LIAISON® Q.S.E.T. Device Plus extraction reproducibility was tested using five (5) stool samples spanning the analytical measuring range of the assay. Samples were extracted using the LIAISON® Q.S.E.T. Device Plus and tested once (1) per day using six (6) replicates over five (5) days by three (3) operators, for a total of 90 measurements per sample. Each LIAISON® Q.S.E.T. Device Plus extraction was performed daily by each operator independently. CLSI document EP15-A3 was consulted in the preparation of the testing protocol.
| Sample
ID | N | mean | Repeatability | | Between-Day | | Within-
Operator | | Between-
Operator | | Total | |
|--------------|----|------|---------------|------|--------------|-------|---------------------|-------|----------------------|-------|--------------|-------|
| | | µg/g | SD
(µg/g) | %CV | SD
(µg/g) | %CV | SD
(µg/g) | %CV | SD
(µg/g) | %CV | SD
(µg/g) | %CV |
| Sample 1 | 90 | 17.2 | 0.42 | 2.5% | 1.39 | 8.1% | 1.45 | 8.4% | 1.26 | 7.3% | 1.81 | 10.5% |
| Sample 2 | 90 | 37.9 | 0.88 | 2.3% | 5.63 | 14.9% | 5.69 | 15.0% | 4.29 | 11.3% | 6.67 | 17.6% |
| Sample 3 | 90 | 120 | 2.43 | 2.0% | 12.1 | 10.1% | 12.3 | 10.3% | 6.29 | 5.2% | 12.7 | 10.6% |
| Sample 4 | 90 | 264 | 7.27 | 2.8% | 29.3 | 11.1% | 30.0 | 11.4% | 24.5 | 9.3% | 36.5 | 13.8% |
| Sample 5 | 90 | 1018 | 36.3 | 3.6% | 119 | 11.7% | 124 | 12.1% | 69.4 | 6.8% | 131 | 12.9% |
Table 6: Precision/Reproducibility
Reproducibility
LIAISON® Q.S.E.T. Device Plus sampling reproducibility was tested using 5 human stool specimens ranging from 2 – 7 on the Bristol Stool Form Scale (BSFS) which were sampled by 3 operators with 5 replicates per specimen per operator on 3 lots of devices for a total of 225 sampling events. The weight of each sample collected by the Q.S.E.T. Device Plus was determined by comparison against the empty device. Repeatability was assessed across all 5 specimens, replicates, operators, and lots.
| Precision of Q.S.E.T. Plus sample weight | ||||||
|---|---|---|---|---|---|---|
| Sample | BSFS | Sample Weight | ||||
| (mg Mean ±SD) | Repeatability | Between-Operator | ||||
| (% CV) | Between-Lot | Within-Lab | ||||
| 1 | 2 | 10.23 ±1.05 | 10.29 | 0.00 | 0.00 | 10.29 |
| 2 | 4 | 11.02 ±0.87 | 7.91 | 0.00 | 0.00 | 7.91 |
| 3 | 6 | 12.00 ±0.71 | 5.56 | 0.00 | 2.04 | 5.93 |
| 4 | 7 | 11.39 ±0.91 | 7.37 | 3.14 | 0.00 | 8.01 |
| 5 | 5 | 11.79 ±0.73 | 6.21 | 0.00 | 0.00 | 6.21 |
Table 8 : Sample collection performance of LIAISON® Q.S.E.T. Device Plus
| Mean Sample Weight | 11.3 mg |
|---|---|
| Median Sample Weight | 11.4 mg |
| Range | 8.5-13.5 mg |
| 95% CI | 11.2-11.4 mg |
| SD | 1.06 |
| %CV | 9.38% |
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REAGENT STABILITY
Table 9: Reagent Stability
| LIAISON Q.S.E.T. Device Plus | Stability |
|---|---|
| 2 - 8°C | 12 months |
SPECIMEN STABILITY
Studies were performed to determine the stability of sample at different storage conditions. The results are provided in the tables below.
Table 10: Specimen Stability
| Stool Specimen | |
|---|---|
| Storage Condition | Stability |
| Refrigerated at 2- 8°C | 72 hours |
| Room temperature (18 - 25°C) | 6 hours |
| Frozen at -20°C | 16 weeks |
| Freeze/Thaw cycles | 3 cycles |
| Sample Extract – LIAISON® Q.S.E.T. Device/Plus Methods | |
|---|---|
| Storage Condition | Stability |
| Room temperature (18 - 25°C) | 4 hours |
| Refrigerated at 2- 8°C | 6 hours |
| Frozen at -20°C | 7 days |
| Freeze/Thaw cycles | 1 cycle |
| Refrigerated at 2- 8°C (with centrifugation) | 7 days |
| Partial Sample Extract - LIAISON® Q.S.E.T. Device Plus Methods | |
|---|---|
| Storage Condition | Stability |
| Room temperature (18 - 25°C) | 8 hours |
| Refrigerated at 2- 8°C | 7 days |
CONCLUSION:
The material submitted in this premarket notification is complete and supports a substantial equivalence decision. The labeling is sufficient and it satisfies the requirements of 21CFR 809.10.