Eonis™ SMA kit
Device Facts
| Record ID | K262893 |
|---|---|
| Device Name | Eonis™ SMA kit |
| Applicant | Revvity, Inc. |
| Product Code | QUE · Immunology |
| Decision Date | Sep 30, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5980 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The Eonis™ SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the Eonis Q or QuantStudio™ Dx Real-Time PCR instrument. This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7. This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.
Device Story
Multiplex real-time PCR assay; detects SMN1 exon 7 and RPP30 (internal control) in DNA extracted from newborn dried blood spots (DBS). Uses Eonis Q or QuantStudio™ Dx Real-Time PCR instruments. Workflow: DNA extraction; PCR master mix setup; amplification; fluorescence detection. Instruments convert fluorescence to cycle threshold (Ct) values. Results interpreted via matrix comparing SMN1 and RPP30 Ct values to identify presumptive normal or presumptive positive samples. Used in newborn screening laboratories by trained technicians. Output informs clinical decision-making by identifying newborns requiring follow-up confirmatory testing for SMA.
Clinical Evidence
Clinical study compared Eonis Q and QuantStudio™ Dx performance using 2079 routine newborn samples and 22 confirmed SMA-positive specimens. Results showed 100% agreement between platforms. Analytical performance included reproducibility and precision studies across multiple sites, operators, and kit lots, demonstrating consistent qualitative results and Ct values. Limit of Blank (LoB) for Eonis Q is zero.
Technological Characteristics
Multiplex real-time PCR assay; utilizes target-specific primers and TaqMan™ probes. Analyzes DNA from dried blood spots. Instruments: Eonis Q or QuantStudio™ Dx. Software: Eonis EASI or Eonis Analysis Software. Qualitative result based on Ct values. Standardized internal control (RPP30) used for validity. No specific material standards cited.
Indications for Use
Indicated for newborn screening for Spinal Muscular Atrophy (SMA) via qualitative detection of homozygous SMN1 exon 7 deletion in DNA from dried blood spots. Not for diagnostic use; positive results require confirmation.
Regulatory Classification
Identification
The Eonis SCID-SMA kit is a multiplex real-time PCR-based assay intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the QuantStudio Dx Real-Time PCR instrument. It is intended for screening of SMA that bear the homozygous deletion of SMN1 exon 7 and is not intended for use as a diagnostic test.
Predicate Devices
- Eonis SCID-SMA kit (DEN200044)
Submission Summary (Full Text)
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 30, 2026
Revvity, Inc.
Lisa Vershave
Regulatory Affairs Manager
77 4th Ave.
Waltham, Massachusetts 02451
Re: K262893
Trade/Device Name: Eonis™ SMA kit
Regulation Number: 21 CFR 866.5980
Regulation Name: Spinal Muscular Atrophy Newborn Screening Test System
Regulatory Class: Class II
Product Code: QUE
Dated: August 17, 2026
Received: August 17, 2026
Dear Lisa Vershave:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262893 - Lisa Vershave
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Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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K262893 - Lisa Vershave
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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-devices/device-advice-comprehensive-regulatory-assistance/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,
PAULA V. CAPOSINO -S
Paula Caposino, Ph.D.
Deputy Director
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K262893
Device Name
Eonis™ SMA kit
Indications for Use (Describe)
The Eonis™ SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on a filter paper and for use on the Eonis Q or QuantStudio™ Dx Real-Time PCR instrument.
This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7.
This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.
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)
**CONTINUE ON A SEPARATE PAGE IF NEEDED.**
This section applies only to requirements of the Paperwork Reduction Act of 1995.
**\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\***
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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740 EF
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revvity
revvity.com
### 8.03.01_510(k) Summary
This summary of safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned number is: K262893
Date: September 30, 2026
| Submitted by: | Revvity, Inc. 77 4th Avenue Waltham, MA US 02451 |
| --- | --- |
| Contact Person: | Lisa Vershave |
| --- | --- |
| | Email: americas.regulatory@revvity.com |
| Trade Name: | Eonis™ SMA kit |
| --- | --- |
| Common Name: | Eonis™ SMA kit |
| --- | --- |
| Regulation: | 21 CFR 866.5980 |
| --- | --- |
| Classification Name: | Spinal Muscular Atrophy Newborn Screening Test System |
| --- | --- |
| Classification: | Immunology |
| --- | --- |
| Product Code: | QUE |
| --- | --- |
| Predicate Device: | Eonis SCID-SMA kit (DEN200044) |
| --- | --- |
Intended Use:
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The Eonis™ SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on filter paper and for use on the Eonis Q or QuantStudio™ Dx Real-Time PCR instrument.
This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7.
This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing.
### Device Description:
The Eonis™ SMA kit contains reagents to detect exon 7 in the SMN1 gene that was submitted and reviewed in DEN200044.
The newborn screening workflow for the Eonis™ SMA Kit includes:
- Two liquid handling platforms (one for DNA extraction and one for PCR master mix setup)
- Eonis Q Instrument or QuantStudio™ Dx Real-Time PCR instrument
- Eonis EASI software (used with Eonis Q instrument) or the Eonis Analysis Software (used with the QuantStudio™ Dx Real-Time PCR instrument)
Each Eonis™ SMA kit contains reagents for up to 384 reactions or 1152 reactions including kit controls. The kit contents are listed in Table 1. Materials required but not provided in the kit include the Eonis DNA Extraction Kit, Eonis EASI software or Eonis Analysis Software, and consumables.
Table 1. Eonis™ SMA kit Content
| Component | Quantity |
| --- | --- |
| SCID-SMA Kit Controls | 2 filter paper cassettes containing 4 sets of dried blood spots for 384 reaction kit4 filter paper cassettes containing 8 sets of dried blood spots for 1152 reaction kit |
| C1 Analyte-negative (SMN1) control | |
| C2 Normal SMN1 control | |
| C3 Normal SMN1 control | |
| PCR Reagent 1 | 1 vial, 2.7 mL for 384 reaction kit3 vials, 2.7 mL each for 1152 reaction kit |
| PCR Reagent 2 | 1 vial, 2.7 mL for 384 reaction kit3 vials, 2.7 mL each for 1152 reaction kit |
| Lot-specific quality control certificate | 1 pc |
### Principle of Operation
The Eonis™ SMA kit is a multiplex real-time PCR-based assay that utilizes target sequence-specific primers and TaqMan™ probes to simultaneously amplify and detect SMN1 exon 7, and RPP30, in DNA extracted from newborn dried blood spots (DBS) using the Eonis DNA Extraction Kit. Targets are amplified within a single PCR reaction.
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Each TaqMan™ probe incorporates a unique fluorescent dye at the 5' end, enabling concurrent detection of all targets when present. During PCR amplification, the probes are cleaved, releasing fluorophores whose emitted signals are measured in real-time by the Eonis Q or QuantStudio™ Dx Real-Time PCR instruments. The instruments convert fluorescence intensity into comparative quantitative results expressed as cycle threshold (Ct) values.
This multiplex real-time PCR approach enables simultaneous detection of the specified targets to support screening for spinal muscular atrophy (SMA) using a single DBS-derived DNA sample.
The interpretation of results based on Ct is shown in Table 2.
Table 2. SMN1 Result Interpretation Matrix
| RPP30 Ct values | | SMN1 Ct values | Result interpretation for SMN1 |
| --- | --- | --- | --- |
| Ct < 15.0 | Values not considered when RPP30 Ct < 15.0 | | Invalid* |
| 15.0 ≤ Ct ≤ 32.00 | AND | Ct < 15.0 | Invalid* |
| | AND | 15.0 ≤ Ct ≤ 31.24 | Presumptive normal |
| | AND | Ct > 31.24 or no Ct | Presumptive positive* |
| Ct > 32.00 or no Ct | Values not considered when RPP30 Ct > 32.00 or no Ct | | Invalid* |
*Samples with invalid results should be repeated in singlicate, samples with presumptive positive results should be repeat tested in duplicate. If one of the duplicate samples is positive, the result is presumptive positive.
### Substantial Equivalence:
The predicate device is the Eonis SCID-SMA Kit cleared under DEN200044. The proposed device, the Eonis™ SMA kit, retains the same SMA assay design, intended use, specimen type, analytes, test methodology, and result interpretation as the predicate device. The assay utilizes multiplex real-time PCR amplification and detection of SMN1 exon 7 and RPP30 from DNA extracted from newborn dried blood spot specimens.
The primary modification is the addition of the Eonis Q instrument and Eonis EASI software as an alternative testing platform to the QuantStudio™ Dx Real-Time PCR Instrument and associated analysis software. The Eonis™ SMA kit may be used with either platform.
Performance testing demonstrated that the addition of the Eonis Q instrument and Eonis EASI software does not affect the performance of the Eonis™ SMA kit. The differences between the proposed device and the predicate device do not raise new questions of safety or effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device.
Table 3. Substantial Equivalency
| Parameter | Predicate: DEN200044 | New Device (changes in bold font) |
| --- | --- | --- |
| Device Trade Name | Eonis SCID-SMA kit | EonisTM SMA kit |
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| Parameter | Predicate: DEN200044 | New Device (changes in bold font) |
| --- | --- | --- |
| **Intended Use / Indications for Use** | The Eonis SCID-SMA kit is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on filter paper and for use on the QuantStudio Dx Real-Time PCR instrument. This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7. This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing. | The **Eonis™ SMA kit** is intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). The test is intended for DNA from blood specimens dried on filter paper and for use on the **Eonis Q** or QuantStudio Dx Real-Time PCR instrument. This test is only intended for use for screening of SMA that bear the homozygous deletion of SMN1 exon 7. This test is not intended for use as a diagnostic test and a positive screening result should be followed by confirmatory testing. |
| **Disorders Screened** | SMA | Same. |
| **Analytes Measured** | SMN1 exon 7 and RPP30 (internal control). | Same. |
| **Test Principle** | The assay amplifies and detects SMN1 exon 7 and RPP30 simultaneously in the DNA extracted from whole blood collected from a heel prick with direct application onto the filter paper (also called Dried Blood Spot, DBS) in a multiplex PCR reaction using target-specific primers and TaqMan probes. | Same. |
| **Sample Requirements** | Dried blood spot. | Same. |
| **Calibrators/Standards** | Calibration is based on internal reference (RPP30) in each well and manufacturer calibration for each kit lot. | Same. |
| **Controls** | C1 Analyte-negative (SMN1) control, C2 Normal SMN1 control, C3 Normal SMN1 control. | Same. |
| **Test Methodology** | Semi-quantitative, multiplex real-time fluorescent-based polymerase chain reaction (PCR) based nucleic acid amplification and detection. | Same. |
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| Parameter | Predicate: DEN200044 | New Device (changes in bold font) |
| --- | --- | --- |
| Instruments / Software | QuantStudio Dx-Real Time PCR Instrument and Eonis Analysis Software. | QuantStudio Dx-Real Time PCR Instrument and Eonis Analysis Software and Eonis Q instrument and Eonis EASI software. |
| Result Types/Calculations | Produce Ct values. | Same. |
| Interpretation of results | SMN1 is qualitative. | Same. |
## Summary of Studies:
### Screening Performance
The screening performance of the Eonis™ SMA kit on Eonis Q and QuantStudio™ Dx instruments was compared in a clinical study at a US newborn screening laboratory. Study population included 2079 routine newborn samples enriched with 20 SMA newborn DBS specimens and 2 non-newborn SMA specimens (with SMN2 copy number 4) that were archived and confirmed positive. The samples were tested according to the testing algorithm described in tables 4.
The SMN1 Ct cut-off is pre-set at 31.24 with both Eonis Q and QuantStudio™ Dx. The screening performance results including the confirmed positive specimens, are present in Table 4.
Table 4. Screening Performance of Eonis™ SMA kit with Eonis Q and QuantStudio™ Dx.
| SMN1 | QuantStudioTM Dx | | Total (%) | |
| --- | --- | --- | --- | --- |
| | | Presumptive positive (%) | | Presumptive normal (%) |
| Eonis Q | Presumptive positive (%) | 22* | 0 | 22 |
| | Presumptive normal (%) | 0 | 2079 | 2079 |
| | Total (%) | 22 | 2079 | 2101 |
*Includes 22 SMA confirmed positive samples
### Analytical Performance
### Reproducibility and Precision
Two studies were performed to determine the reproducibility and precision of the Eonis™ SMA kit using a panel of dried blood spots at different SMN1 levels. Hematocrits were adjusted between 40%-55% with normal RPP30 levels.
All 104 plates from both studies had results of the Kit Controls within the acceptance limits. The data validity check for 3757 wells resulted in no exclusions from the analysis (sample invalid rate is 0%).
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### Site-to-Site Reproducibility
The objective of this study was to characterize the within-laboratory precision and reproducibility of the Eonis Q across 3 study sites. Setup included 1 reagent kit lot, 2 external newborn screening laboratories and 1 internal site. In each laboratory, 2 operators performed 5 runs each during 5 operating days. Each run consisted of 1 plate with 5 replicates per sample. Total number of measurements was 150 per sample (50 replicates per sample in each laboratory).
For qualitative analyte, SMN1, the precision is presented as the percent agreement of qualitative results interpreted with respect to cut-off 31.24 Ct for each sample in Table 5, for SMN1 Ct values in Table 6, and RPP30 Ct values in Table 7 for Eonis Q.
Table 5. SMN1 reproducibility data.
| Sample | N | Proportion Below Cut-off (%) (with 95% CI) | Proportion Above Cut-off (%) (with 95% CI) |
| --- | --- | --- | --- |
| 1 | 150 | 100% (97.6% - 100%) | 0 |
| 2 | 150 | 100% (97.6% - 100%) | 0 |
| 3 | 150 | 100% (97.6% - 100%) | 0 |
| 4 | 150 | 100% (97.6% - 100%) | 0 |
| 5 | 150 | 100% (97.6% - 100%) | 0 |
| 6 | 150 | 100% (97.6% - 100%) | 0 |
| 7 | 150 | 100% (97.6% - 100%) | 0 |
| 8 | 150 | 100% (97.6% - 100%) | 0 |
| 9 | 150 | 100% (97.6% - 100%) | 0 |
| 10 | 150 | 100% (97.6% - 100%) | 0 |
| 11 | 150 | 0 | 100% (97.6% - 100%) |
| 12 | 150 | 100% (97.6% - 100%) | 0 |
| 13 | 150 | 100% (97.6% - 100%) | 0 |
| 14 | 150 | 100% (97.6% - 100%) | 0 |
| 15 | 150 | 100% (97.6% - 100%) | 0 |
Table 6. SMN1 reproducibility analysis on Ct values for samples. All replicate results for Sample 11 (SMA positive) are “No Ct” and thus not included in the table.
| Sample | N | CT Mean | Within Run | | Between Run | | Between Operator | | Between Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 150 | 24.6 | 0.38 | 1.5 | 0.00 | 0.0 | 0.00 | 0.0 | 0.14 | 0.6 | 0.40 | 1.6 |
| 2 | 150 | 24.5 | 0.46 | 1.9 | 0.16 | 0.6 | 0.00 | 0.0 | 0.06 | 0.2 | 0.49 | 2.0 |
| 3 | 150 | 24.5 | 0.58 | 2.4 | 0.04 | 0.2 | 0.00 | 0.0 | 0.26 | 1.1 | 0.64 | 2.6 |
| 4 | 150 | 25.8 | 0.37 | 1.4 | 0.00 | 0.0 | 0.00 | 0.0 | 0.12 | 0.5 | 0.39 | 1.5 |
| 5 | 150 | 26.1 | 0.34 | 1.3 | 0.11 | 0.4 | 0.02 | 0.1 | 0.18 | 0.7 | 0.41 | 1.6 |
| 6 | 150 | 25.0 | 0.30 | 1.2 | 0.08 | 0.3 | 0.00 | 0.0 | 0.19 | 0.7 | 0.36 | 1.4 |
| 7 | 150 | 26.1 | 0.48 | 1.8 | 0.06 | 0.2 | 0.00 | 0.0 | 0.15 | 0.6 | 0.50 | 1.9 |
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| Sample | N | CT Mean | Within Run | | Between Run | | Between Operator | | Between Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 8 | 150 | 26.4 | 0.33 | 1.2 | 0.00 | 0.0 | 0.02 | 0.1 | 0.15 | 0.6 | 0.36 | 1.4 |
| 9 | 150 | 24.9 | 0.35 | 1.4 | 0.07 | 0.3 | 0.00 | 0.0 | 0.10 | 0.4 | 0.37 | 1.5 |
| 10 | 150 | 27.8 | 0.43 | 1.5 | 0.13 | 0.5 | 0.00 | 0.0 | 0.16 | 0.6 | 0.48 | 1.7 |
| 12 | 150 | 25.9 | 0.36 | 1.4 | 0.10 | 0.4 | 0.08 | 0.3 | 0.14 | 0.6 | 0.41 | 1.6 |
| 13 | 150 | 24.9 | 0.39 | 1.6 | 0.08 | 0.3 | 0.06 | 0.2 | 0.09 | 0.3 | 0.41 | 1.7 |
| 14 | 150 | 26.9 | 0.36 | 1.3 | 0.13 | 0.5 | 0.00 | 0.0 | 0.09 | 0.3 | 0.39 | 1.4 |
| 15 | 150 | 24.8 | 0.34 | 1.4 | 0.10 | 0.4 | 0.00 | 0.0 | 0.16 | 0.7 | 0.39 | 1.6 |
Table 7. RPP30 reproducibility analysis on Ct values.
| Sample | N | CT Mean | Within Run | | Between Run | | Between Operator | | Between Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 150 | 25.7 | 0.44 | 1.7 | 0.17 | 0.7 | 0.00 | 0.0 | 0.07 | 0.3 | 0.48 | 1.9 |
| 2 | 150 | 25.7 | 0.53 | 2.1 | 0.15 | 0.6 | 0.00 | 0.0 | 0.04 | 0.2 | 0.55 | 2.2 |
| 3 | 150 | 25.7 | 0.62 | 2.4 | 0.20 | 0.8 | 0.00 | 0.0 | 0.23 | 0.9 | 0.69 | 2.7 |
| 4 | 150 | 27.0 | 0.47 | 1.8 | 0.21 | 0.8 | 0.00 | 0.0 | 0.08 | 0.3 | 0.53 | 1.9 |
| 5 | 150 | 27.3 | 0.47 | 1.7 | 0.30 | 1.1 | 0.00 | 0.0 | 0.20 | 0.7 | 0.59 | 2.2 |
| 6 | 150 | 26.4 | 0.42 | 1.6 | 0.25 | 0.9 | 0.00 | 0.0 | 0.13 | 0.5 | 0.51 | 1.9 |
| 7 | 150 | 27.3 | 0.61 | 2.3 | 0.18 | 0.6 | 0.00 | 0.0 | 0.11 | 0.4 | 0.65 | 2.4 |
| 8 | 150 | 27.7 | 0.42 | 1.5 | 0.29 | 1.1 | 0.00 | 0.0 | 0.13 | 0.5 | 0.53 | 1.9 |
| 9 | 150 | 25.3 | 0.46 | 1.8 | 0.19 | 0.7 | 0.00 | 0.0 | 0.13 | 0.5 | 0.52 | 2.0 |
| 10 | 150 | 28.5 | 0.73 | 2.6 | 0.00 | 0.0 | 0.00 | 0.0 | 0.35 | 1.2 | 0.81 | 2.8 |
| 11 | 150 | 24.1 | 0.40 | 1.7 | 0.15 | 0.6 | 0.00 | 0.0 | 0.17 | 0.7 | 0.46 | 1.9 |
| 12 | 150 | 27.1 | 0.44 | 1.6 | 0.27 | 1.0 | 0.00 | 0.0 | 0.09 | 0.3 | 0.53 | 1.9 |
| 13 | 150 | 26.3 | 0.52 | 2.0 | 0.00 | 0.0 | 0.00 | 0.0 | 0.03 | 0.1 | 0.52 | 2.0 |
| 14 | 150 | 28.2 | 0.43 | 1.5 | 0.21 | 0.7 | 0.00 | 0.0 | 0.15 | 0.6 | 0.50 | 1.8 |
| 15 | 150 | 25.4 | 0.47 | 1.9 | 0.10 | 0.4 | 0.00 | 0.0 | 0.17 | 0.7 | 0.52 | 2.0 |
### Lot-to-lot Reproducibility
This study was performed internally (single site) using 3 sets of Eonis Q at least 2 operators and 3 kit lots. The samples 1-14 were tested over a minimum of 23 calendar days with 2 replicates per sample per plate in a total of 72 runs for Eonis Q with a randomized plate map. Total number of measurements were 108 per sample.
For qualitative analyte, SMN1, the precision is presented as the percent agreement of qualitative results interpreted with respect to cut-off 31.24 Ct for each sample in Table 8, for SMN1 Ct values in Table 19 and for RPP30 Ct values in Table 10 for Eonis Q.
Table 8. SMN1 precision data.
| Sample | N | N (below cut-off) | Proportion Normal (%) (with 95% CI) | N (above cut-off) | Proportion Positive (%) (with 95% CI) |
| --- | --- | --- | --- | --- | --- |
| 1 | 107 | 107 | 100 (96.6%-100.0%) | 0 | 0 |
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{11}
| Sample | N | N (below cut-off) | Proportion Normal (%) (with 95% CI) | N (above cut-off) | Proportion Positive (%) (with 95% CI) |
| --- | --- | --- | --- | --- | --- |
| 2 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 3 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 4 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 5 | 107 | 107 | 100 (96.6%-100.0%) | 0 | 0 |
| 6 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 7 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 8 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 9 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 10 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 11 | 106 | 0 | 0 | 106 | 100 (96.6%-100.0%) |
| 12 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 13 | 108 | 108 | 100 (96.6%-100.0%) | 0 | 0 |
| 14 | 107 | 107 | 100 (96.6%-100.0%) | 0 | 0 |
Table 9. SMN1 precision analysis on Ct values for samples. All replicate results for Sample 11 are “No Ct” and thus not included in the table.
| Sample | N | Mean Ct | Repeatability | | Between Run | | Between System | | Within Lot | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV % | SD | CV % | SD | CV % | SD | CV % | SD | CV % | SD | CV % |
| 1 | 107 | 24.4 | 0.42 | 1.7 | 0.13 | 0.5 | 0.15 | 0.6 | 0.47 | 1.9 | 0.17 | 0.7 | 0.50 | 2.0 |
| 3 | 108 | 24.4 | 0.50 | 2.1 | 0.27 | 1.1 | 0.12 | 0.5 | 0.59 | 2.4 | 0.18 | 0.7 | 0.61 | 2.5 |
| 2 | 108 | 24.5 | 0.33 | 1.4 | 0.14 | 0.6 | 0.17 | 0.7 | 0.39 | 1.6 | 0.10 | 0.4 | 0.41 | 1.7 |
| 13 | 108 | 24.8 | 0.30 | 1.2 | 0.00 | 0.0 | 0.16 | 0.6 | 0.34 | 1.4 | 0.08 | 0.3 | 0.35 | 1.4 |
| 9 | 108 | 24.8 | 0.29 | 1.2 | 0.15 | 0.6 | 0.00 | 0.0 | 0.33 | 1.3 | 0.11 | 0.5 | 0.35 | 1.4 |
| 6 | 108 | 24.8 | 0.26 | 1.0 | 0.23 | 0.9 | 0.10 | 0.4 | 0.36 | 1.4 | 0.09 | 0.4 | 0.37 | 1.5 |
| 4 | 108 | 25.6 | 0.28 | 1.1 | 0.19 | 0.7 | 0.14 | 0.5 | 0.37 | 1.4 | 0.09 | 0.3 | 0.38 | 1.5 |
| 12 | 108 | 25.8 | 0.33 | 1.3 | 0.14 | 0.5 | 0.07 | 0.3 | 0.37 | 1.4 | 0.07 | 0.3 | 0.37 | 1.4 |
| 7 | 108 | 25.9 | 0.37 | 1.4 | 0.22 | 0.8 | 0.00 | 0.0 | 0.43 | 1.7 | 0.15 | 0.6 | 0.45 | 1.8 |
| 5 | 107 | 26.0 | 0.32 | 1.2 | 0.12 | 0.5 | 0.14 | 0.5 | 0.37 | 1.4 | 0.06 | 0.2 | 0.38 | 1.4 |
| 8 | 108 | 26.4 | 0.31 | 1.2 | 0.13 | 0.5 | 0.00 | 0.0 | 0.34 | 1.3 | 0.16 | 0.6 | 0.37 | 1.4 |
| 14 | 107 | 26.8 | 0.34 | 1.3 | 0.12 | 0.4 | 0.19 | 0.7 | 0.41 | 1.5 | 0.11 | 0.4 | 0.42 | 1.6 |
| 10 | 108 | 27.8 | 0.38 | 1.4 | 0.19 | 0.7 | 0.13 | 0.5 | 0.44 | 1.6 | 0.27 | 1.0 | 0.52 | 1.9 |
Table 10. RPP30 precision analysis on Ct values.
| Sample | N | Mean Ct | Repeatability | | Between Run | | Between System | | Within Lot | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV % | SD | CV % | SD | CV % | SD | CV % | SD | CV % | SD | CV % |
| 11 | 106 | 24.1 | 0.33 | 1.4 | 0.17 | 0.7 | 0.07 | 0.3 | 0.38 | 1.6 | 0.02 | 0.1 | 0.38 | 1.6 |
| 9 | 108 | 25.3 | 0.41 | 1.6 | 0.00 | 0.0 | 0.00 | 0.0 | 0.41 | 1.6 | 0.10 | 0.4 | 0.42 | 1.7 |
| 3 | 108 | 25.7 | 0.60 | 2.4 | 0.14 | 0.6 | 0.00 | 0.0 | 0.62 | 2.4 | 0.09 | 0.4 | 0.63 | 2.4 |
| 1 | 107 | 25.7 | 0.40 | 1.6 | 0.21 | 0.8 | 0.09 | 0.4 | 0.46 | 1.8 | 0.09 | 0.4 | 0.47 | 1.8 |
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| Sample | N | Mean Ct | Repeatability | | Between Run | | Between System | | Within Lot | | Between Lot | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | CV % | SD | CV % | SD | CV % | SD | CV % | SD | CV % | SD | CV % |
| 2 | 108 | 25.7 | 0.45 | 1.7 | 0.00 | 0.0 | 0.07 | 0.3 | 0.46 | 1.8 | 0.08 | 0.3 | 0.46 | 1.8 |
| 13 | 108 | 26.2 | 0.40 | 1.5 | 0.19 | 0.7 | 0.00 | 0.0 | 0.44 | 1.7 | 0.04 | 0.2 | 0.45 | 1.7 |
| 6 | 108 | 26.3 | 0.39 | 1.5 | 0.07 | 0.3 | 0.11 | 0.4 | 0.42 | 1.6 | 0.03 | 0.1 | 0.42 | 1.6 |
| 4 | 108 | 26.9 | 0.44 | 1.6 | 0.18 | 0.7 | 0.09 | 0.3 | 0.48 | 1.8 | 0.01 | 0.0 | 0.48 | 1.8 |
| 12 | 108 | 27.2 | 0.47 | 1.7 | 0.14 | 0.5 | 0.12 | 0.4 | 0.51 | 1.9 | 0.09 | 0.3 | 0.51 | 1.9 |
| 7 | 108 | 27.2 | 0.43 | 1.6 | 0.19 | 0.7 | 0.08 | 0.3 | 0.47 | 1.7 | 0.02 | 0.1 | 0.47 | 1.7 |
| 5 | 107 | 27.3 | 0.42 | 1.5 | 0.11 | 0.4 | 0.15 | 0.6 | 0.46 | 1.7 | 0.09 | 0.3 | 0.47 | 1.7 |
| 8 | 108 | 27.8 | 0.43 | 1.6 | 0.05 | 0.2 | 0.17 | 0.6 | 0.47 | 1.7 | 0.05 | 0.2 | 0.47 | 1.7 |
| 14 | 107 | 28.1 | 0.43 | 1.5 | 0.00 | 0.0 | 0.16 | 0.6 | 0.46 | 1.6 | 0.09 | 0.3 | 0.46 | 1.6 |
| 10 | 108 | 28.4 | 0.61 | 2.2 | 0.18 | 0.6 | 0.05 | 0.2 | 0.64 | 2.3 | 0.08 | 0.3 | 0.65 | 2.3 |
### Limit of Blank (LoB)
The Limit of Blank (LoB) was determined in accordance with CLSI document EP17-A2. The data for LoB was analyzed using “Assign LoB = Zero and Confirm” approach. The LoB of the Eonis Q is zero for SMN1 and RPP30.
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