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 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
The Eonis™ SMA kit is an in vitro diagnostic test for newborn screening of Spinal Muscular Atrophy (SMA). It utilizes multiplex PCR to detect the SMN1 gene exon 7 from 3.2 mm dried blood spot (DBS) punches. The workflow involves automated DNA extraction and purification, followed by real-time PCR analysis on the Eonis Q instrument. The Eonis EASI software processes the PCR signals, using an internal reference (RPP30) for calibration. The system outputs qualitative results (presumptive normal or presumptive positive) based on Ct value thresholds. It is intended for use in clinical laboratory settings by trained personnel. Positive screening results require follow-up confirmatory testing. The device benefits patients by enabling early identification of SMA, facilitating timely clinical intervention.
Clinical Evidence
Clinical study conducted at a US newborn screening laboratory using 2079 routine newborn samples and 22 confirmed SMA-positive specimens. The study compared the Eonis Q instrument against the predicate QuantStudio™ Dx. Results showed 100% sensitivity (95% CI: 84.6-100%) and 100% specificity (95% CI: 99.8-100%). No false positives or false negatives were observed in the routine screening population.
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 dried blood spot specimens. Not for diagnostic use.
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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[LOGO]
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## DECISION SUMMARY
ASSAY AND INSTRUMENT
### I Background Information:
A 510(k) Number
K262893
B Applicant
Revvity, Inc.
C Proprietary and Established Names
Eonis™ SMA kit
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QUE | Class II | 21 CFR 866.5980 Spinal Muscular Atrophy Newborn Screening Test System | Immunology |
### II Submission/Device Overview:
A Purpose for Submission:
Adding a new instrument to the test system
B Measurand:
Survival Motor Neuron 1 (SMN1)
C Type of Test:
Multiplex polymerase chain reaction (PCR)
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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### III Intended Use/Indications for Use:
#### A Intended Use(s):
See Indications for Use below.
#### B Indication(s) 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 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.
#### C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
In vitro diagnostic use
#### D Special Instrument Requirements:
Eonis Q instrument
### IV Device/System Characteristics:
#### A Device Description:
The Eonis™ SMA kit contains reagents to detect exon 7 in the SMN1 gene. 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
- Eonis EASI software (used with Eonis Q instrument)
See DEN200044 for more information about kit contents.
#### B Principle of Operation:
See DEN200044 for principle of operation
#### C Instrument Description Information:
1. Instrument Name:
Eonis Q instrument
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# 2. Specimen Identification:
Specimens are barcoded and entered into the testing queue consistent with the laboratory procedures.
# 3. Specimen Sampling and Handling:
The required sample type of the assay is a 3.2 mm specimen punch from a dried blood spot (DBS) into a 96-well plate. DNA is extracted and purified using a method developed internally by modifying and re-optimizing the protocols published by Gerstel-Thompson JL et al. and Saavedra-Matiz CA et al. The automated extraction can be completed manually or using a liquid handling platform such as JANUS, for processing up to four 96-well plates simultaneously. Please refer to DEN200044 for the DNA extraction equivalency.
# 4. Calibration:
Calibration is based on internal reference (RPP30) in each well and manufacturer calibration for each kit lot.
# 5. Quality Control:
See DEN200044 for quality control information.
# V Substantial Equivalence Information:
A Predicate Device Name(s):
Eonis SCID-SMA Kit
B Predicate 510(k) Number(s):
DEN200044
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K262893 | DEN200044 |
| --- | --- | --- |
| Device Trade Name | Eonis™ SMA kit | Eonis SCID-SMA Kit |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Intended for the qualitative detection of the SMN1 gene exon 7 as an aid in screening newborns for Spinal Muscular Atrophy (SMA). This test is only | Same |
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| Device & Predicate Device(s): | K262893 | DEN200044 |
| --- | --- | --- |
| | 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. | |
| Specimen | Dried blood spot | Same |
| **General Device Characteristic Differences** | | |
| Instrument | Eonis Q Instrument | QuantStudio™ Dx-Real Time PCR Instrument |
| Software | Eonis EASI software | QuantStudio™ Dx Software |
### VI Standards/Guidance Documents Referenced:
UL 61010-1:2012 R7.19 — Standard for Safety for Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1: General Requirements
IEC 61326-2-6:2025 — Electrical Equipment for Measurement, Control, and Laboratory Use, EMC Requirements; Part 2-6: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment
CLSI EP05-A3 — Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline, Third Edition
CLSI EP06-ED02 — Evaluation of the Linearity of Quantitative Measurement Procedures; 2nd Edition
CLSI EP17-A2 — Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline, Second Edition
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## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
#### 1. Precision/Reproducibility:
##### *Study 1: Site-to-Site Reproducibility*
The objective of this study was to characterize the within-laboratory precision and reproducibility of the Eonis test system across 3 study sites (1 internal and 2 external newborn screening laboratories) using a panel of samples. At each study site, 2 operators performed 5 runs each, over 5 non-consecutive operating days, 1 run per day, and 5 specimen replicates tested per run. A total of 15 independent samples were tested at each of the 3 study sites using 1 kit lot for a total of 150 replicates per sample.
A description of the specimens used is provided in the following table:
| Sample | SMN1 |
| --- | --- |
| Sample 1 | Normal |
| Sample 2 | Normal |
| Sample 3 | Normal |
| Sample 4 | Normal |
| Sample 5 | Normal |
| Sample 6 | Normal |
| Sample 7 | Normal |
| Sample 8 | Normal |
| Sample 9 | Normal |
| Sample 10 | Carrier-like (heterozygous deletion of exon 7) |
| Sample 11 | Negative (homozygous deletion of exon 7) |
| Sample 12 | Normal |
| Sample 13 | Normal |
| Sample 14 | Normal |
| Sample 15 | Normal |
| 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 |
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| Sample | N | Proportion Below Cut-off (%) (with 95% CI) | Proportion Above Cut-off (%) (with 95% CI) |
| --- | --- | --- | --- |
| 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 |
SMN1 reproducibility data
| Sample | Ct Mean | Within Run | | Between Run | | Between Operator | | Between Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 24.6 | 0.38 | 1.5 | 0.00 | 0.0 | 0.00 | 0.0 | 0.14 | 0.6 | 0.40 | 1.6 |
| 2 | 24.5 | 0.46 | 1.9 | 0.16 | 0.6 | 0.00 | 0.0 | 0.06 | 0.2 | 0.49 | 2.0 |
| 3 | 24.5 | 0.58 | 2.4 | 0.04 | 0.2 | 0.00 | 0.0 | 0.26 | 1.1 | 0.64 | 2.6 |
| 4 | 25.8 | 0.37 | 1.4 | 0.00 | 0.0 | 0.00 | 0.0 | 0.12 | 0.5 | 0.39 | 1.5 |
| 5 | 26.1 | 0.34 | 1.3 | 0.11 | 0.4 | 0.02 | 0.1 | 0.18 | 0.7 | 0.41 | 1.6 |
| 6 | 25.0 | 0.30 | 1.2 | 0.08 | 0.3 | 0.00 | 0.0 | 0.19 | 0.7 | 0.36 | 1.4 |
| 7 | 26.1 | 0.48 | 1.8 | 0.06 | 0.2 | 0.00 | 0.0 | 0.15 | 0.6 | 0.50 | 1.9 |
| 8 | 26.4 | 0.33 | 1.2 | 0.00 | 0.0 | 0.02 | 0.1 | 0.15 | 0.6 | 0.36 | 1.4 |
| 9 | 24.9 | 0.35 | 1.4 | 0.07 | 0.3 | 0.00 | 0.0 | 0.10 | 0.4 | 0.37 | 1.5 |
| 10 | 27.8 | 0.43 | 1.5 | 0.13 | 0.5 | 0.00 | 0.0 | 0.16 | 0.6 | 0.48 | 1.7 |
| 12 | 25.9 | 0.36 | 1.4 | 0.10 | 0.4 | 0.08 | 0.3 | 0.14 | 0.6 | 0.41 | 1.6 |
| 13 | 24.9 | 0.39 | 1.6 | 0.08 | 0.3 | 0.06 | 0.2 | 0.09 | 0.3 | 0.41 | 1.7 |
| 14 | 26.9 | 0.36 | 1.3 | 0.13 | 0.5 | 0.00 | 0.0 | 0.09 | 0.3 | 0.39 | 1.4 |
| 15 | 24.8 | 0.34 | 1.4 | 0.10 | 0.4 | 0.00 | 0.0 | 0.16 | 0.7 | 0.39 | 1.6 |
Results for Sample 11 are “No Ct” and thus not included in the table.
RPP30 reproducibility data
| Sample | Ct Mean | Within Run | | Between Run | | Between Operator | | Between Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 25.7 | 0.44 | 1.7 | 0.17 | 0.7 | 0.00 | 0.0 | 0.07 | 0.3 | 0.48 | 1.9 |
| 2 | 25.7 | 0.53 | 2.1 | 0.15 | 0.6 | 0.00 | 0.0 | 0.04 | 0.2 | 0.55 | 2.2 |
| 3 | 25.7 | 0.62 | 2.4 | 0.20 | 0.8 | 0.00 | 0.0 | 0.23 | 0.9 | 0.69 | 2.7 |
| 4 | 27.0 | 0.47 | 1.8 | 0.21 | 0.8 | 0.00 | 0.0 | 0.08 | 0.3 | 0.53 | 1.9 |
| 5 | 27.3 | 0.47 | 1.7 | 0.30 | 1.1 | 0.00 | 0.0 | 0.20 | 0.7 | 0.59 | 2.2 |
| 6 | 26.4 | 0.42 | 1.6 | 0.25 | 0.9 | 0.00 | 0.0 | 0.13 | 0.5 | 0.51 | 1.9 |
| 7 | 27.3 | 0.61 | 2.3 | 0.18 | 0.6 | 0.00 | 0.0 | 0.11 | 0.4 | 0.65 | 2.4 |
| 8 | 27.7 | 0.42 | 1.5 | 0.29 | 1.1 | 0.00 | 0.0 | 0.13 | 0.5 | 0.53 | 1.9 |
| 9 | 25.3 | 0.46 | 1.8 | 0.19 | 0.7 | 0.00 | 0.0 | 0.13 | 0.5 | 0.52 | 2.0 |
| 10 | 28.5 | 0.73 | 2.6 | 0.00 | 0.0 | 0.00 | 0.0 | 0.35 | 1.2 | 0.81 | 2.8 |
| 11 | 24.1 | 0.40 | 1.7 | 0.15 | 0.6 | 0.00 | 0.0 | 0.17 | 0.7 | 0.46 | 1.9 |
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| Sample | Ct Mean | Within Run | | Between Run | | Between Operator | | Between Site | | Total | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 12 | 27.1 | 0.44 | 1.6 | 0.27 | 1.0 | 0.00 | 0.0 | 0.09 | 0.3 | 0.53 | 1.9 |
| 13 | 26.3 | 0.52 | 2.0 | 0.00 | 0.0 | 0.00 | 0.0 | 0.03 | 0.1 | 0.52 | 2.0 |
| 14 | 28.2 | 0.43 | 1.5 | 0.21 | 0.7 | 0.00 | 0.0 | 0.15 | 0.6 | 0.50 | 1.8 |
| 15 | 25.4 | 0.47 | 1.9 | 0.10 | 0.4 | 0.00 | 0.0 | 0.17 | 0.7 | 0.52 | 2.0 |
### Study 2: Lot-to-Lot Reproducibility
A study was performed internally (single site) using 3 sets of Eonis test systems, 3 operators, and 3 kit lots. The 14 samples were tested over 36 calendar days with 2 replicates per sample per plate in a total of 72 runs with a randomized plate map. The total number of measurements was 108 per sample.
| Sample | N | Proportion Below Cut-off (%) (with 95% CI) | Proportion Above Cut-off (%) (with 95% CI) |
| --- | --- | --- | --- |
| 1 | 107 | 100% (96.6% - 100%) | 0 |
| 2 | 108 | 100% (96.6% - 100%) | 0 |
| 3 | 108 | 100% (96.6% - 100%) | 0 |
| 4 | 108 | 100% (96.6% - 100%) | 0 |
| 5 | 107 | 100% (96.6% - 100%) | 0 |
| 6 | 108 | 100% (96.6% - 100%) | 0 |
| 7 | 108 | 100% (96.6% - 100%) | 0 |
| 8 | 108 | 100% (96.6% - 100%) | 0 |
| 9 | 108 | 100% (96.6% - 100%) | 0 |
| 10 | 108 | 100% (96.6% - 100%) | 0 |
| 11 | 106 | 0 | 100% (96.6% - 100%) |
| 12 | 108 | 100% (96.6% - 100%) | 0 |
| 13 | 108 | 100% (96.6% - 100%) | 0 |
| 14 | 107 | 100% (96.6% - 100%) | 0 |
| 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 | 0.5 | 2 |
| 2 | 108 | 24.5 | 0.33 | 1.4 | 0.14 | 0.6 | 0.17 | 0.7 | 0.39 | 1.6 | 0.1 | 0.4 | 0.41 | 1.7 |
| 3 | 108 | 24.4 | 0.5 | 2.1 | 0.27 | 1.1 | 0.12 | 0.5 | 0.59 | 2.4 | 0.18 | 0.7 | 0.61 | 2.5 |
| 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 |
| 5 | 107 | 26 | 0.32 | 1.2 | 0.12 | 0.5 | 0.14 | 0.5 | 0.37 | 1.4 | 0.06 | 0.2 | 0.38 | 1.4 |
| 6 | 108 | 24.8 | 0.26 | 1 | 0.23 | 0.9 | 0.1 | 0.4 | 0.36 | 1.4 | 0.09 | 0.4 | 0.37 | 1.5 |
| 7 | 108 | 25.9 | 0.37 | 1.4 | 0.22 | 0.8 | 0 | 0 | 0.43 | 1.7 | 0.15 | 0.6 | 0.45 | 1.8 |
| 8 | 108 | 26.4 | 0.31 | 1.2 | 0.13 | 0.5 | 0 | 0 | 0.34 | 1.3 | 0.16 | 0.6 | 0.37 | 1.4 |
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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 % |
| 9 | 108 | 24.8 | 0.29 | 1.2 | 0.15 | 0.6 | 0 | 0 | 0.33 | 1.3 | 0.11 | 0.5 | 0.35 | 1.4 |
| 10 | 108 | 27.8 | 0.38 | 1.4 | 0.19 | 0.7 | 0.13 | 0.5 | 0.44 | 1.6 | 0.27 | 1 | 0.52 | 1.9 |
| 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 |
| 13 | 108 | 24.8 | 0.3 | 1.2 | 0 | 0 | 0.16 | 0.6 | 0.34 | 1.4 | 0.08 | 0.3 | 0.35 | 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 |
Results for Sample 11 are “No Ct” and thus not included in the table.
RPP30 reproducibility data
| 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 | 25.7 | 0.4 | 1.6 | 0.21 | 0.8 | 0.09 | 0.4 | 0.46 | 1.8 | 0.09 | 0.4 | 0.47 | 1.8 |
| 2 | 108 | 25.7 | 0.45 | 1.7 | 0 | 0 | 0.07 | 0.3 | 0.46 | 1.8 | 0.08 | 0.3 | 0.46 | 1.8 |
| 3 | 108 | 25.7 | 0.6 | 2.4 | 0.14 | 0.6 | 0 | 0 | 0.62 | 2.4 | 0.09 | 0.4 | 0.63 | 2.4 |
| 4 | 108 | 26.9 | 0.44 | 1.6 | 0.18 | 0.7 | 0.09 | 0.3 | 0.48 | 1.8 | 0.01 | 0 | 0.48 | 1.8 |
| 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 |
| 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 |
| 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 |
| 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 |
| 9 | 108 | 25.3 | 0.41 | 1.6 | 0 | 0 | 0 | 0 | 0.41 | 1.6 | 0.1 | 0.4 | 0.42 | 1.7 |
| 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 |
| 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 |
| 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 |
| 13 | 108 | 26.2 | 0.4 | 1.5 | 0.19 | 0.7 | 0 | 0 | 0.44 | 1.7 | 0.04 | 0.2 | 0.45 | 1.7 |
### 2. Linearity:
Not applicable
### 3. Analytical Specificity/Interference:
See DEN200044
### 4. Detection Limit and Assay Reportable Range:
The LoB study was performed using contrived analyte negative samples created by spiking a SMN1-negative Coriell cell line into leukocyte depleted blood which is analyte negative for SMN1. The Coriell cell line was added to a target of 30,000 genome-copies/ \( \mu \) L. The study was performed by at least one operator using an Eonis Q, two kit lots and 2 runs per day over 5 days totaling 10 runs (150 results for both kit lots). All the replicates had no Ct value and, thus, false positive rates were 0% with both kit lots.
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The LoB of RPP30 was established by running the replicates of blank filter paper with no template DNA. For RPP30, the percentage of false positive results was also 0% for both kit lots.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
See DEN200044 for kit/sample stability
6. Assay Cut-Off:
Not applicable
# B Comparison Studies:
1. Method Comparison with Predicate Device:
Not applicable
2. Matrix Comparison:
Not applicable
# C Clinical Studies:
1. Clinical Sensitivity:
Not applicable
2. Clinical Specificity:
Not applicable
3. Clinical Cut-Off
| 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 ≤ 32.0 | AND | Ct < 15.0 | Invalid* |
| | AND | 15.0 ≤ Ct ≤ 31.24 | Presumptive normal |
| | AND | Ct > 31.24 or no Ct | Presumptive positive* |
| Ct > 32.0 or no Ct | Values not considered when RPP30 Ct > 32.0 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.
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# 4. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
The screening performance of the Eonis SCID-SMA kit on Eonis Q and QuantStudio™ Dx instruments was compared in a clinical study at a US newborn screening laboratory. The 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.
Specimens were to be retested in duplicate according to the testing algorithm if the initial screening result was presumptive positive for any of the analytes. Specimens were tested in parallel using the candidate device and predicate device. For both devices, routine newborn screening specimens with initial presumptive positive screening results were retested. Confirmed positive specimens were not retested due to the limited quantities available.
| Routine screening samples | Investigational device | Predicate device |
| --- | --- | --- |
| Screened samples | 2079 | 2079 |
| Initial screen positive | 0 | 0 |
| Initial screen negative | 2079 | 2079 |
| Retest rate | 0% | 0% |
| Final screen positive | 0 | 0 |
| Final screen negative | 2079 | 2079 |
| False-positive rate | 0% | 0% |
| SMN1 | QuantStudio™ 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
| | Sensitivity | Specificity | Accuracy | False positive rate | False negative rate | PPV | NPV |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Percent | 100% | 100% | 100% | 0% | 0% | 100% | 100% |
| Confidence interval | 84.6-100% | 99.8-100% | 99.8-100% | 0-0.2% | 0-15.4% | | |
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### D Expected Values/Reference Range:
The distribution of a newborn screening population was determined by analyzing a total of 3139 unique specimens from a newborn screening laboratory in the United States. Invalid or duplicate results were excluded (n=120), so the statistics below were calculated based on 3019 samples.
| | N | Ct Median | P 98.5 | P 99.0 | P 99.5 | P 99.9 |
| --- | --- | --- | --- | --- | --- | --- |
| SMN1 | 3019 | 24.1 | 25.66 | 25.82 | 26.06 | 26.67 |
### E Other Supportive Instrument Performance Characteristics Data:
The sponsor performed carryover studies, with the observed carryover percentage of 0%.
Electrical safety and electromagnetic compatibility (EMC) testing were performed, and the system was found to be acceptable.
Software and cybersecurity documentation was reviewed and found to be acceptable.
### VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
### IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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