(73 days)
Not Found
No
The description details a standard chemiluminescent immunoassay run on an automated platform. The calculation of results is based on a predefined master curve and a generated working curve, which is a standard method in quantitative immunoassays and does not indicate the use of AI/ML. There are no mentions of AI, ML, or related concepts in the document.
No.
This device is an in vitro diagnostic (IVD) device used to aid in the diagnosis of idiopathic inflammatory myopathy (IIM) by detecting specific autoantibodies, not for treating or preventing a disease.
Yes
The device is an aid in the diagnosis of idiopathic inflammatory myopathy (IIM), as stated in the 'Intended Use / Indications for Use' section.
No
The device is an in vitro diagnostic (IVD) assay that requires specific reagents and runs on a dedicated hardware instrument (BIO-FLASH®). While it includes software for processing results, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "semi-quantitative determination of IgG autoantibodies against HMGCR... in human serum." This is a test performed on a biological sample (serum) outside of the body to provide information for diagnosis.
- Aid in Diagnosis: The intended use also states it is "an aid in the diagnosis of idiopathic inflammatory myopathy (IIM)." This directly links the test results to providing diagnostic information.
- Device Description: The description details a "chemiluminescent immunoassay" performed on a "human serum sample." This is a common type of in vitro diagnostic test.
- Performance Studies: The document includes extensive performance studies (precision, reproducibility, LoD, LoQ, linearity, interference, sample stability, reagent stability, and clinical performance) which are standard requirements for IVD devices to demonstrate their analytical and clinical validity.
- Key Metrics: The inclusion of sensitivity, specificity, PPV, and NPV are key metrics used to evaluate the clinical performance of diagnostic tests.
- Predicate Device: The mention of a predicate device (K151429; QUANTA Flash Jo-1) which is also an IVD, further supports the classification of this device as an IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
QUANTA Flash HMGCR is a chemiluminescent immunoassay for the semi-quantitative determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigen in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy (IIM).
Product codes
LLL
Device Description
The principle of the assay is chemiluminescent microparticle immunoassay, a variation of solid phase immunoassay. The QUANTA Flash® HMGCR assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash® HMGCR assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH® instrument.
HMGCR (3-hydroxy-3-methylglutary)-coenzyme A reductase) antigen is coated on to paramagnetic beads, which are stored in the reagent cartridge lyophilized. When the assay cartridge is ready to be used for the first time, a buffer solution is added to the tube containing the beads, and the beads are resuspended with the buffer. The reagent cartridge is then loaded onto the BIO-FLASH instrument.
A patient serum sample is diluted 1:17 by the instrument in a disposable plastic cuvette. An aliquot of the diluted patient serum, HMGCR-coupled beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is incubated at 37°C. The beads are then magnetized and washed several times. Isoluminol conjugated anti-human IgG antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when "Trigger" reagents are added to the light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. RLU values are proportional to the amount of bound isoluminol conjugate, which in turn is proportional to the amount of anti-HMGCR antibodies bound to the antigen on the beads. The QUANTA Flash HMGCR assay utilizes a predefined lot specific Master Curve that is uploaded into the instrument through the reagent cartridge barcode. Based on the results obtained by running two calibrators, an instrument specific Working Curve is created, which is used by the software to calculate chemiluminescent units (CU) from the RLU value obtained for each sample.
QUANTA Flash HMGCR Calibrators and QUANTA Flash HMGCR Controls are sold separately.
The QUANTA Flash HMGCR Reagents kit contains the following materials:
- a. One (1) QUANTA Flash HMGCR Reagent Cartridge
- b. One (1) tube of Resuspension Buffer
- One (1) transfer pipette ﻥ
The QUANTA Flash HMGCR reagent cartridge contains the following reagents for 50 determinations:
- a. HMGCR coated paramagnetic beads, lyophilized.
- b. Assay buffer colored pink, containing protein stabilizers and preservatives.
- c. Tracer IgG Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
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
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Intended User / Care Setting
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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
A cohort of characterized samples, none of which were used for establishing the reference range, was used to validate the clinical performance of the QUANTA Flash HMGCR. A total of 723 characterized samples were included in the Validation Set for the QUANTA Flash HMGCR. All samples were run on the QUANTA Flash HMGCR.
Summary of Performance Studies
The precision of the QUANTA Flash HMGCR assay was evaluated on 7 samples containing various concentrations of antibodies in accordance with CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Procedures - Approved Guideline. Samples were run in duplicates, twice a day, for 20 days. Data were analyzed with the Analyse-it for Excel method evaluation software, and repeatability (withinrun), between run, between day and within-laboratory precision) were calculated. Acceptance criteria: Total %CV:
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
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June 25, 2018
Inova Diagnostics, Inc. Roger Albesa Manager, Research and Development 9900 Old Grove Rd. San Diego, California 92131-1638
Re: K180975
Trade/Device Name: QUANTA Flash HMGCR Reagents Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: LLL Dated: April 12, 2018 Received: April 13, 2018
Dear Roger Albesa:
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 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.
Kelly Oliner -S
For
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180975
Device Name QUANTA Flash HMGCR Reagents
Indications for Use (Describe)
QUANTA Flash HMGCR is a chemiluminescent immunoassay for the semi-quantitative determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigen in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy (IIM).
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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510(k) Summary
QUANTA Flash® HMGCR Reagents
Page 1 of 13
Table of Contents |
---|
Administrative data…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… |
Predicate device |
Device description |
Intended use(s) |
Indications for use |
Substantial equivalence |
Comparison to predicate device |
Analytical performance characteristics |
Quantitation and units of measure |
Value assignment and traceability of Calibrators and Controls Error! Bookmark not defined. |
Precision |
Reproducibility Studies |
Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ) |
Analytical Measuring Range (AMR) |
Auto-rerun function and reportable results |
High concentration hook effect |
Linearity |
Interference |
Sample Stability and Handling |
Reagent Stability |
Cut-off, reference range |
Clinical performance characteristics |
Clinical sensitivity, specificity |
Expected values |
Comparison with predicate device |
References |
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This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Administrative data
| Submitter: | Inova Diagnostics, Inc
9900 Old Grove Road,
San Diego, CA, 92131 | | | | | |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--|--|--|--|
| Purpose of submission: | New device(s) | | | | | |
| Devices in the submission: | QUANTA Flash® HMGCR Reagents | | | | | |
| Scientific contact: | Roger Albesa, Manager, Research and Development
Inova Diagnostics, Inc.
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900 x1391
Fax: 858-863-0025
Email: ralbesa@inovadx.com | | | | | |
| Quality Systems contact: | Ronda Elliott, VP, Quality Systems and RA
Inova Diagnostics, Inc
9900 Old Grove Road, San Diego, CA, 92131
Phone: 858-586-9900/1381
Fax: 858-863-0025
Email: relliot@inovadx.com | | | | | |
| Device name (assay kit): | Proprietary name: | QUANTA Flash® HMGCR Reagents | | | | |
| | Common name: | anti-3-hydroxy-3-methylglutaryl-coenzyme A
reductase (HMGCR) Chemiluminescent
Immunoassay | | | | |
| | Classification name: | autoantibodies, HMGCR | | | | |
| Regulation Description | Extractable antinuclear antibody, antigen and control | | | | | |
| Regulation Medical Specialty | Immunology | | | | | |
| Review Panel | Immunology | | | | | |
| Product Code | LLL | | | | | |
| Regulation Number | 866.5100 | | | | | |
| Device Class | 2 | | | | | |
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510(k) Summary QUANTA Flash® HMGCR
Predicate device
QUANTA Flash Jo-1, 510(k) number: K151429. Date declared: February 12, 2016.
Device description
The principle of the assay is chemiluminescent microparticle immunoassay, a variation of solid phase immunoassay. The QUANTA Flash® HMGCR assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash® HMGCR assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH® instrument.
HMGCR (3-hydroxy-3-methylglutary)-coenzyme A reductase) antigen is coated on to paramagnetic beads, which are stored in the reagent cartridge lyophilized. When the assay cartridge is ready to be used for the first time, a buffer solution is added to the tube containing the beads, and the beads are resuspended with the buffer. The reagent cartridge is then loaded onto the BIO-FLASH instrument.
A patient serum sample is diluted 1:17 by the instrument in a disposable plastic cuvette. An aliquot of the diluted patient serum, HMGCR-coupled beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is incubated at 37°C. The beads are then magnetized and washed several times. lsoluminol conjugated anti-human IgG antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when "Trigger" reagents are added to the light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. RLU values are proportional to the amount of bound isoluminol conjugate, which in turn is proportional to the amount of anti-HMGCR antibodies bound to the antigen on the beads. The QUANTA Flash HMGCR assay utilizes a predefined lot specific Master Curve that is uploaded into the instrument through the reagent cartridge barcode. Based on the results obtained by running two calibrators, an instrument specific Working Curve is created, which is used by the software to calculate chemiluminescent units (CU) from the RLU value obtained for each sample.
QUANTA Flash HMGCR Calibrators and QUANTA Flash HMGCR Controls are sold separately.
The QUANTA Flash HMGCR Reagents kit contains the following materials:
- a. One (1) QUANTA Flash HMGCR Reagent Cartridge
- b. One (1) tube of Resuspension Buffer
- One (1) transfer pipette ﻥ
The QUANTA Flash HMGCR reagent cartridge contains the following reagents for 50 determinations:
- a. HMGCR coated paramagnetic beads, lyophilized.
- b. Assay buffer colored pink, containing protein stabilizers and preservatives.
- c. Tracer IgG Isoluminol labeled anti-human IgG antibody, containing buffer, protein stabilizers and preservative.
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Intended use(s)
QUANTA Flash HMGCR is a chemiluminescent immunoassay for the semi-quantitative determination of lgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigens in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy (IIM).
Indications for use
Same as Intended use.
Substantial equivalence
The QUANTA Flash HMGCR Reagents has the same intended use and assay principle as the predicate device.
Comparison to predicate device
QUANTA Flash HMGCR Reagents
Similarities | ||
---|---|---|
Item | QUANTA Flash HMGCR Reagents | QUANTA Flash Jo-1 Reagents |
Intended use | QUANTA Flash HMGCR is a chemiluminescent immunoassay for the semi-quantitative determination of IgG autoantibodies against HMGCR (3-hydroxy-3-methylglutaryl-coenzyme A reductase) antigen in human serum. The presence of anti-HMGCR antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy (IIM). | QUANTA Flash Jo-1 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-Jo-1 antibodies in human serum. The presence of anti-Jo-1 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of idiopathic inflammatory myopathy |
Assay methodology | Solid phase (heterogeneous) immunoassay | Solid phase (heterogeneous) immunoassay |
Solid phase | Paramagnetic microparticles (beads) | Paramagnetic microparticles (beads) |
Detection/ | ||
Operating principle | Chemiluminescent immunoassay | Chemiluminescent immunoassay |
Conjugate | Isoluminol conjugated anti-human IgG | Isoluminol conjugated anti-human IgG |
Shelf life | One year | One year |
Sample type | Serum | Serum |
Calibration | Lot specific Master Curve + two calibrators (sold separately) | Lot specific Master Curve + two calibrators (sold separately) |
Units | CU (Chemiluminescent units) (arbitrary) | CU (Chemiluminescent units) (arbitrary) |
Differences | ||
Item | QUANTA Flash HMGCR Reagents | QUANTA Flash Jo-1 Reagents |
Antigen | Recombinant HMGCR | Recombinant Jo-1 |
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Analytical performance characteristics
Quantitation and units of measure
For quantitation, the QUANTA Flash HMGCR assay utilizes a lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. The Master Curve for QUANTA Flash HMGCR consists of 6 Standards. These Master Curve Standards are used to create the lot specific Master Curve during the manufacturing procedure.
List of HMGCR Standards:
Material | Assigned Value |
---|---|
HMGCR Master Curve Standard 1 | 0.0 CU |
HMGCR Master Curve Standard 2 | 6.9 CU |
HMGCR Master Curve Standard 3 | 20.8 CU |
HMGCR Master Curve Standard 4 | 62.4 CU |
HMGCR Master Curve Standard 5 | 187.2 CU |
HMGCR Master Curve Standard 6 | 561.6 CU |
Precision
The precision of the QUANTA Flash HMGCR assay was evaluated on 7 samples containing various concentrations of antibodies in accordance with CLSI EP05-A3, Evaluation of Precision Performance of Quantitative Measurement Procedures - Approved Guideline. Samples were run in duplicates, twice a day, for 20 days.
Data were analyzed with the Analyse-it for Excel method evaluation software, and repeatability (withinrun), between run, between day and within-laboratory precision) were calculated.
Acceptance criteria: Total %CV: 550.0 CU after further diluting it by 20 fold, thereby bringing the measured value within the AMR. The final result will be calculated by the software by taking into account the additional dilution factor. As the highest value that can be directly measured is 550.0 CU, the highest value that can be reported is 11,000.0 CU.
High concentration hook effect
To assess hook effect, measurement signal in relative light units (RLU) was examined by performing serial dilutions of two high positive samples (with results above the AMR when tested as neat samples). RLU values showed increase with increasing antibody concentrations above the AMR, thereby confirming that high positive specimens above the AMR do not show hook effect up to 5,193.6 CU (theoretical value calculated using the highest value in the AMR and its dilution factor) in the QUANTA Flash HMGCR assay.
Linearity
The linearity of the AMR of the QUANTA Flash HMGCR was evaluated by a study according to CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach;
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Approved Guideline. The linearity was evaluated using four human serum samples with various anti-HMGCR antibody concentrations which were combined with another human serum sample containing low levels of anti-HMGCR antibodies in 10% increments (from 0% to 90% of low sample) to obtain values that cover the entire AMR. The dilutions were assayed in duplicates. Results were analyzed according to the guideline performing regression analysis and identifying the best fitting polynomial. Acceptance criteria:
- Best fitting polynomial is a linear one, otherwise, the difference between the best-fitting nonlinear and linear polynomial is less than 15% or ±3 CU for negative samples (allowable nonlinearity).
All samples have been found that the best fitting polynomial is a linear one except Sample 3, where the best fitting polynomial found was a second order polynomial. The nonlinearity for Sample 3 ranged from -0.4 CU to 0.6 CU, fulfilling the acceptance criteria.
| Serum
Samples | Test Range
(CU) | Slope
(95% CI) | Y-Intercept
(95% CI) | R2 | Average %
Recovery |
|------------------|--------------------|------------------------|-------------------------|------|-----------------------|
| 1 | 610.2 to 61.0 | 0.97
(0.92 to 1.01) | 3.9
(-3.5 to 11.3) | 1.00 | 98.5% |
| 2 | 138.0 to 13.8 | 0.98
(0.95 to 1.01) | -0.1
(-1.3 to 1.05) | 1.00 | 97.7% |
| 3 | 21.5 to 2.2 | 0.94
(0.91 to 0.98) | 0.0
(-0.2 to 0.2) | 1.00 | 94.0% |
| 4 | 10.4 to 1.0 | 1.03
(0.99 to 1.06) | 0.0
(-0.1 to 0.1) | 1.00 | 103.2% |
| Combined | 610.2 to 1.0 | 0.98
(0.96 to 0.99) | 0.1
(0.0 to 0.2) | 1.00 | 98.4% |
All four samples showed dilution linearity individually and in combination.
These data demonstrate the linearity of the analytical measuring range (1.5 CU – 550.0 CU) of the QUANTA Flash HMGCR assay.
Interference
The interference study was performed according to CLSI EPO7-A2, Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition. A first set of four human serum specimens, one high positive, one moderately positive, one near the cutoff and one negative sample were tested using the following interfering substances (bilirubin, hemoglobin, triglycerides, cholesterol, human IgG and rheumatoid factor IgM). Additionally a second set of four human serum specimens, one moderately positive, one low positive, one near the cutoff and one negative sample were tested using the following interfering substances (atorvastatin, simvastatin, coenzyme Q, pyrroloquinoline quinone and methylprednisolone). All interferents were spiked at three different concentration levels into every specimen in 10% of total specimen volume, and the resulting samples were assessed in triplicates with the QUANTA Flash HMGCR assay. Recovery of the unit values was calculated compared to control samples spiked with the same volume of diluents (10% of total sample volume). Acceptance criteria for the interference studies were 85% - 115% recovery, or ± 15% of the cut-off (±3 CU) difference, whichever is greater.
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No interference was detected with bilirubin up to 1 mg/mL (recovery: 95.5% to 106.7%), hemoglobin up to 2 mg/mL (recovery: 85.2% to 102.4%), triglycerides up to 1000 mg/dL (recovery: 87.9% to 99.5%), cholesterol up to 332.5 mg/dL (recovery: 90.1% to 101.1%), human IgG up to 35 mg/mL (recovery: 97.5% to 113.9%), rheumatoid factor IgM up to 153.4 IU/mL (recovery: 88.7% to 100.9%), atorvastatin up to 600 ng/mL (recovery: 100.0% to 105.2%), simvastatin up to 600 ng/mL (recovery: 94.4% to 104.7%), coenzyme Q up to 0.72 mg/mL (recovery: 105.0% to 110.8%), pyrroloquinoline quinone up to 24 µg/mL (recovery: 100.8% to 104.6%) and methylprednisolone up to 36 µg/mL (recovery: 100.4% to 111.8%).
Sample Stability and Handling
Four samples, encompassing negative, around the cut-off, moderate positive and high positive samples were tested in duplicates for up to 14 days while stored at 2-8°C, up to 48 hours while stored at room temperature, and after repeated freeze/thaw cycles up to 3 cycles. Results were compared to those obtained on control samples (day zero, stored at 2-8°C).
Acceptance criteria: 85-115% average recovery.
All samples fulfilled the acceptance criteria at each time point for each condition. Based on these result, we recommend that samples are stored up to 48 hours at room temperature, up to 14 days at 2-8°C, and can be subjected to up to 3 freeze/thaw cycles (when samples are stored at or below -20°C).
Reagent Stability
Shelf life
To establish the initial claim for shelf life, accelerated stability studies were performed for 3 weeks at 37 °C, where one week is equal to six months at 5 ± 3°C.
Accelerated stability testing was performed on each of the following sealed components which are exclusive of the QUANTA Flash HMGCR to establish initial stability claim:
- HMGCR beads (3 Lots)
Each week a new sealed component was placed in the incubator, and all components were tested at the end of the experiment together with the one that was stored at 5 ± 3°C. The recovery of the measured values was calculated for each time point (compared to those obtained with 5 ± 3°C stored reagent). All calculations were performed by comparing results of sealed components stored at 5 ± 3℃ (control) to those stored at 37 ± 3℃ (test) for 1, 2 and 3 weeks, where one week is equal to six months at 5 ± 3℃. Linear regression analysis was performed between recovery values and the number of days.
Acceptance criteria for one year preliminary expiration dating:
With regression analysis, the lower and upper 95% Cl interval of the regression line is between 80% and 120% recovery at day 14.
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All components tested fulfilled the acceptance criteria above, so one year expiration dating was assigned to each component
In-use (onboard) stability
Reagent Cartridge
To establish the in-use stability of the QUANTA Flash HMGCR reagent cartridge, two lots of reagent cartridge were tested with 4 to 6 serum specimens (with different reactivity levels). The specimens were tested periodically for a minimum of 61 days. Percent recoveries were calculated compared to the day zero average values, and linear regression analysis was performed by plotting percent recovery against the number of days. The claim was established using the following criteria (using the one that is fulfilled first):
-
The stability claim is established at the actual measurement day proceeding the 95% confidence interval of the regression line reaches 85% or 115% recovery, or
-
At the actual measurement day preceding the day when ≥2% of the recovery data, (3 data points) is