(151 days)
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No
The document describes a quality control material for a genetic assay and does not mention any AI or ML components.
No
The device is an in vitro diagnostic quality control for monitoring the performance of a genotyping assay, not for treating any condition.
No
The device is described as a "quality control" material for an in vitro diagnostic genotyping assay, not the diagnostic assay itself. It monitors the performance of the diagnostic assay.
No
The device is a physical quality control material (synthetic DNA in a blood-like matrix) used in an in vitro diagnostic assay, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".
- Purpose: The device is used to monitor the analytical performance of a genotyping assay, which is a diagnostic test performed outside of the body (in vitro) on biological samples.
- Device Description: It is a quality control material used in the process of performing a diagnostic test.
- Performance Studies: The document describes performance studies conducted to validate the device's use in a diagnostic setting.
N/A
Intended Use / Indications for Use
HemosIL FII & FV DNA Control is intended for the quality control of the Xpert HemosIL FII & FV genotyping assay on the GeneXpert Dx System.
HemosIL FII & FV DNA Control is intended for in vitro diagnostic use as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection steps of the Xpert™ HemosIL FII & FV genotyping assay on the GeneXpert® Dx System used in the detection of both the Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.
Product codes
NZB
Device Description
HemosIL FII & FV DNA Control is synthetic Factor V DNA suspended in a non-infectious blood-like matrix. Each vial includes normal and mutated Factor II and Factor V DNA sequences and is configured as a heterozygous control for both Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.
The quality control material is validated for use with Xpert™ HemosIL® FII & FV genotyping assay on the GeneXpert® Dx System and is processed exactly as whole blood samples during the extraction, amplification and detection steps.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All Test Results
For the stability and performance studies, three lots of HemosIL FII & FV DNA Control were manufactured and tested using the Xpert HemosIL FII & FV Assay on the GeneXpert Dx system. Testing was conducted both internally at the control manufacturer and externally at multiple sites.
Number of Sites: 8
Number of Tests: 201
Correct Genotype: 201 (FII Heterozygous/FV Heterozygous)
Incorrect Result: 0
Indeterminate Result: 1 (Operator error; one test was repeated)
Percent Correct: 100%
In all cases, genotypes were called correctly.
External Site Testing
HemosIL FII & FV DNA Control was tested at seven external sites using the Xpert HemosIL FII & FV Assay on the GeneXpert Dx System:
- Site Nos. 1 and 2: Two clinical laboratory sites in Europe tested one lot of control daily in duplicate for six days (n=12 per site) with a different operator at each site.
- Site No. 3: One site at the instrument/assay manufacturer (Cepheid) tested three lots of control in duplicate (n=6) with a single operator.
- Site No. 4: One site at Instrumentation Laboratory Co. tested one lot of control in singlicate for thirty days (n=30) with a single operator and a second lot of control in singlicate for 6 days (n=6).
- Site Nos. 5-7: Three clinical laboratory sites in the United States tested one lot of control in singlicate for ten days (n=10 per site) with a different operator at each site.
Site No. 1: 12 tests, 12 correct, 0 incorrect, 1 indeterminate (operator error), 100% correct
Site No. 2: 12 tests, 12 correct, 0 incorrect, 0 indeterminate, 100% correct
Site No. 3: 6 tests, 6 correct, 0 incorrect, 0 indeterminate, 100% correct
Site No. 4: 36 tests, 36 correct, 0 incorrect, 0 indeterminate, 100% correct
Site No. 5: 10 tests, 10 correct, 0 incorrect, 0 indeterminate, 100% correct
Site No. 6: 10 tests, 10 correct, 0 incorrect, 0 indeterminate, 100% correct
Site No. 7: 10 tests, 10 correct, 0 incorrect, 0 indeterminate, 100% correct
In all cases, genotypes were called correctly.
Reproducibility (Within-run)
Within-run reproducibility was demonstrated with one operator by testing two lots of HemosIL FII & FV DNA Control in 5 replicates of five using a single lot of Xpert HemosIL Factor. Genotypes were called correctly. Within-run reproducibility was excellent, with Ct SD.
Control Lot #A21FEB08 (Assay Lot #201): 5 tests, 5 correct. FII G Normal Mean Ct 27.3, SD 0.4. FII A Mutant Mean Ct 26.4, SD 0.5. FV G Normal Mean Ct 27.3, SD 0.6. FV A Mutant Mean Ct 27.4, SD 0.7.
Control Lot #B26FEB08 (Assay Lot #201): 5 tests, 5 correct. FII G Normal Mean Ct 27.0, SD 0.5. FII A Mutant Mean Ct 25.9, SD 0.4. FV G Normal Mean Ct 26.8, SD 0.4. FV A Mutant Mean Ct 27.0, SD 0.3.
Control Lot #A21FEB08 (Assay Lot #301): 5 tests, 5 correct. FII G Normal Mean Ct 25.9, SD 0.3. FII A Mutant Mean Ct 25.4, SD 0.3. FV G Normal Mean Ct 26.1, SD 0.4. FV A Mutant Mean Ct 26.2, SD 0.4.
Reproducibility (Lot-to-lot)
Lot-to-lot reproducibility was demonstrated by testing three lots of HemosIL FII & FV DNA Control using a single HemosIL Factor II & Factor V Assay on the GeneXpert Dx. In all cases, genotypes were called correctly. No significant differences were seen between control lots, with Ct SD
§ 866.5910 Quality control material for cystic fibrosis nucleic acid assays.
(a)
Identification. Quality control material for cystic fibrosis nucleic acid assays. A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.
0
KC093737
510(k) Summary
MAY - 4 2010
Applicant Contact Information:
| Applicant: | Instrumentation Laboratory Co. |
|---|---|
| Address: | 180 Hartwell Road |
| Bedford, MA 01730 | |
| Contact Person: | Carol Marble, Regulatory Affairs Director |
| Phone Number: | 781-861-4467 |
| Fax Number: | 781-861-4207 |
| Preparation Date: | December 3, 2009 |
Device Trade Name:
HemosIL® FII & FV DNA Control
Device Regulatory Information:
| Regulation No.: | 21 CFR 866.5910 |
|---|---|
| Regulation Name: | Quality Control, Genetics, DNA |
| Regulatory Class: | Class II |
| Product Code: | NZB |
| Panel: | Immunology (82) |
Predicate Device:
| K083171 | INTROLTM CF Panel I Control |
|---|---|
| --------- | ----------------------------- |
Device Description:
HemosIL FII & FV DNA Control is synthetic Factor V DNA suspended in a non-infectious blood-like matrix. Each vial includes normal and mutated Factor II and Factor V DNA sequences and is configured as a heterozygous control for both Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.
The quality control material is validated for use with Xpert™ HemosIL® FII & FV genotyping assay on the GeneXpert® Dx System and is processed exactly as whole blood samples during the extraction, amplification and detection steps.
Device Intended Use:
HemosIL FII & FV DNA Control is intended for the quality control of the Xpert HemosIL FII & FV genotyping assay on the GeneXpert Dx System.
.
1
510(k) Summary (Cont.)
Substantial Equivalence:
| Differences and
Similarities | Predicate Device (K083171):
INTROL CF Panel I Control | New Device:
HemosIL FII & FV DNA Control |
|------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Physical Composition | Synthetic (recombinant) DNA
with non-human carrier DNA,
preservatives, dye and stabilizers | Same |
| Physical Format | Ready-to-use liquid | Same |
| Gene Segment | CFTR (38 mutations; 4 variants) | Factor II (20210G>A)
Factor V (1691G>A Leiden
mutation) |
| Assay Steps
Monitored | Extraction, Amplification and
Detection | Same |
| Recommended
Storage | 2-8°C | Same |
| Method to Validate
Presence Mutations | Bi-directional sequencing | Same |
| Directions for Use | Handle control in the same
manner as the patient sample | Same |
Summary Performance Data:
All Test Results
For the stability and performance studies, three lots of HemosIL FII & FV DNA Control were manufactured and tested using the Xpert HemosIL FII & FV Assay on the GeneXpert Dx system. Testing was conducted both internally at the control manufacturer and externally at multiple sites as detailed in the table on the next page.
In all cases, genotypes were called correctly.
| Number
of Sites | Number of
Tests | Correct Genotype:
FII Heterozygous/
FV Heterozygous) | Incorrec
t Result | Indeterminate
Result | Percent
Correct |
|--------------------|--------------------|------------------------------------------------------------|----------------------|-------------------------|--------------------|
| 8 | 201 | 201 | 0 | 1* | 100% |
- Operator error; one test was repeated
2
510(k) Summary (Cont.)
Summary Performance Data (Cont.):
External Site Testing
- HemosIL FII & FV DNA Control was tested at seven external sites using the Xpert HemosIL . FII & FV Assay on the GeneXpert Dx System:
- Site Nos. 1 and 2: Two clinical laboratory sites in Europe tested one lot of control daily in . duplicate for six days (n=12 per site) with a different operator at each site.
- Site No. 3: One site at the instrument/assay manufacturer (Cepheid) tested three lots of . control in duplicate (n=6) with a single operator.
- Site No. 4: One site at Instrumentation Laboratory Co. tested one lot of control in . singlicate for thirty days (n=30) with a single operator and a second lot of control in singlicate for 6 days (n=6).
- Site Nos. 5-7: Three clinical laboratory sites in the United States tested one lot of control . in singlicate for ten days (n= 10 per site) with a different operator at each site.
| Site | Number
of Tests | Correct Genotype:
FII Heterozygous/
FV Heterozygous) | Incorrec
t Result | Indeterminate
Result | Percent
Correct |
|------------|--------------------|------------------------------------------------------------|----------------------|-------------------------|--------------------|
| Site No. 1 | 12 | 12 | 0 | 1* | 100% |
| Site No. 2 | 12 | 12 | 0 | 0 | 100% |
| Site No. 3 | 6 | 6 | 0 | 0 | 100% |
| Site No. 4 | 36 | 36 | 0 | 0 | 100% |
| Site No. 5 | 10 | 10 | 0 | 0 | 100% |
| Site No. 6 | 10 | 10 | 0 | 0 | 100% |
| Site No. 7 | 10 | 10 | 0 | 0 | 100% |
In all cases, genotypes were called correctly.
- Operator error; one test was repeated
3
0(k) Summary (Con
Summary Performance Data (Cor
eproducibili
- ough HemosIL FII & FV DNA Control is a qualitative control (genotype present or absent), the GeneXpert Dr. provides mudi NOTE
- -Run Testing: With-in run reproducibility was demonstrated with one operator by tesing two lots of HemolL FII & FV DN
cates of five using a single lot of Xpert HemosiL Factor
genotypes were called correctly. Within-run reproducibility was excellent, with Ct SD
| Control Lot # | No. of
Tests | Assay
Lot # | Correct Results
(FII Heterozygous/
FV Heterozygous) | FII G Normal
Mean Ct | FII G Normal
SD | FII A Mutant
Mean Ct | FII A Mutant
SD | FV G Normal
Mean Ct | FV G Normal
SD | FV A Mutant
Mean Ct | FV A Mutant
SD |
|---------------|-----------------|----------------|-----------------------------------------------------------|-------------------------|--------------------|-------------------------|--------------------|------------------------|-------------------|------------------------|-------------------|
| A21FEB08 | 5 | 201 | 5 | 27.3 | 0.4 | 26.4 | 0.5 | 27.3 | 0.6 | 27.4 | 0.7 |
| B26FEB08 | 5 | 201 | 5 | 27.0 | 0.5 | 25.9 | 0.4 | 26.8 | 0.4 | 27.0 | 0.3 |
| A21FEB08 | 5 | 301 | 5 | 25.9 | 0.3 | 25.4 | 0.3 | 26.1 | 0.4 | 26.2 | 0.4 |
- Lot Testing: Lot-lot reproducibility was demonstrated by testing three lots of Hemos!L FII & FV DNA Control using a sin
emosIL Factor II & Factor V Assay on the GeneXpert Dx
ases, genotypes were called correctly. No significant differences were seen between control lots, with Ct SD A and Factor V 1691G>A (Leiden) mutations.
V Prescription Use _ (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnos Device Evaluation and S
510K K093737