(46 days)
No
The summary describes a reagent kit for DNA sequencing and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as a set of reagents and consumables used for processing human genomic DNA samples for targeted re-sequencing, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the processing of human genomic DNA samples and subsequent targeted re-sequencing, which are steps in diagnostic testing, and is explicitly named "MiSeqDx Universal Kit 1.0", where "Dx" stands for diagnostics.
No
The device is described as a set of reagents and consumables, which are physical components, not software. It is intended for use with a separate instrument (MiSeqDx instrument/Platform), further indicating it is not a standalone software device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is used in the "processing of human genomic DNA samples derived from peripheral whole blood" and "targeted re-sequencing of the resulting sample libraries." This involves analyzing biological samples (blood) outside of the body (in vitro).
- Sample Type: The device processes "human genomic DNA samples derived from peripheral whole blood." Blood is a biological sample commonly used in diagnostic testing.
- Purpose: While the kit itself doesn't provide a specific diagnosis, it is a crucial component of a system (the MiSeqDx Platform) that is used for "targeted re-sequencing." This type of genetic analysis is frequently used in clinical settings for diagnostic purposes (e.g., identifying genetic mutations associated with diseases).
- Intended User/Care Setting: The intended users are "clinical laboratories," which are the typical setting for performing in vitro diagnostic tests.
- Performance Studies: The document references performance studies related to reproducibility, accuracy, and impact of interferents, which are standard evaluations for IVD devices to demonstrate their reliability for clinical use.
- Reference Device: It references the "Illumina MiSeqDx platform" (K123989), which is a known IVD platform used for genetic testing.
The fact that it requires "User-supplied analyte specific reagents" for targeting specific genomic regions further reinforces its role as a component within a larger diagnostic workflow. The kit provides the universal reagents for the sequencing process, and the specific diagnostic application is determined by the user-supplied reagents targeting relevant genes or regions.
N/A
Intended Use / Indications for Use
The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
2. Indication for uses(s):
Same as Intended use above.
Product codes
PFT
Device Description
The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx Platform.
The MiSeqDx Universal Kit 1.0 consists of 5 boxes :
Box 1A Pre-Amp reagents :
Component: Hybridization Buffer, Active Ingredients: Buffered aqueous solution containing salts and formamide
Component: Extension-Ligation Mix, Active Ingredients: Buffered aqueous solution containing proprietary blend of DNA polymerases, DNA ligase, and dNTPs
Component: Index Primers A (A501) - H (A508), Active Ingredients: PCR primers with index sequences and sequencing adapters
Component: Index Primers 1 (A701) - 12 (A712), Active Ingredients: PCR primers with index sequences and sequencing adapters
Component: PCR Polymerase, Active Ingredients: Proprietary DNA polymerase
Component: PCR Master Mix, Active Ingredients: Buffered aqueous solution containing salts and dNTPs
Box 1B Post-Amp Reagents
Component: Library Normalization Diluent, Active Ingredients: Buffered aqueous solution containing salts, 2-Mercaptoethanol, and formamide
Component: Library Dilution Buffer, Active Ingredients: Buffered aqueous solution
Component: PhiX Internal Control, Active Ingredients: Buffered aqueous solution containing PhiX genomic DNA
Box 2 Post-Amp Reagents
Component: MiSeqDx Reagent Cartridge, Contents: Single-use cartridge that contains cluster generation and sequencing reagents for use with the MiSeqDx, including formamide, 2-Mercaptoethanol, and
§ 862.3800 Reagents for molecular diagnostic instrument test systems.
(a)
Identification. Reagents for molecular diagnostic test systems are reagents other than analyte specific reagents used as part of molecular diagnostic test systems, such as polymerases, nucleotides and nucleotide mixes, master mixes in which individual reagents are optimized to be used together, and labeled nucleic acid molecules.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedure in subpart E of part 807 of this chapter, subject to the limitations in § 862.9.
0
EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR MISEQDX UNIVERSAL KIT 1.0
DECISION SUMMARY
| A. 510(k) Number: | K133136 |
|---|---|
| B. Purpose for Submission: | De novo request for evaluation of automatic class |
| III designation of the MiSeqDx Universal Kit 1.0 | |
| C. Measurand: | Not applicable. Reagents for the creation of a |
| Library specimen from a sample of human genomic | |
| DNA obtained from peripheral whole blood | |
| D. Type of Test: | Not applicable: Reagents for preparation of a |
| library specimen for use with high-throughput | |
| genomic sequence analyzer | |
| E. Applicant: | Illumina Inc. |
| F. Proprietary and Established Name: | MiSeqDx Universal Kit 1.0 |
G. Regulatory Information:
FDA identifies this type of device as:
-
- New regulation number: 21 CFR 862.3800
-
- Classification: Class I
-
- Product code: PFT Reagents for molecular diagnostic test systems
-
- Panel: Toxicology (91)
H. Intended Use:
- 1.Intended uses(s):
The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.
1
2. Indication for uses(s):
Same as Intended use above.
-
- Special conditions for use statement(s):
For in vitro diagnostic use.
- Special conditions for use statement(s):
For prescription use only.
-
- This product is limited to delivering:
- . Sequencing output >1 Gb
- . Reads >3 million
- Read length (in paired end run) 2 x 150 bp
- . Bases higher than Q30 >75% (Greater than 75% of bases have Phred scale quality score greater than 30, indicating base call accuracy greater than 99.9% )
-
- The system has been validated for the detection of SNVs and up to 3 base deletions. Evaluation of 1 base insertions was been limited to 3 different insertions on 3 separate chromosomes.
-
- The system has problems detecting 1 base insertions or deletions in homopolymer tracts (e.g. polyA).
-
- This MiSeqDx system is designed to deliver qualitative (i.e. genotype) results.
-
- As with any hybridization-based workflow, underlying polymorphisms or mutations in oligonucleotide-binding regions can affect the alleles being probed and, consequently, the calls made.
-
- Recommended minimal coverage per amplicon needed for accurate variant calling (Q(max_gt | poly_site) >= 100) is 75x.
4. Special instrument requirements:
For use with the Illumina MiSeqDx platform (K123989).
I. Device Description:
The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx Platform.
2
The MiSeqDx Universal Kit 1.0 consists of 5 boxes :
| Component | Active Ingredients |
|---|---|
| Hybridization Buffer | Buffered aqueous solution containing salts and |
| formamide | |
| Extension-Ligation Mix | Buffered aqueous solution containing |
| proprietary blend of DNA polymerases, DNA | |
| ligase, and dNTPs | |
| Index Primers A (A501) - H (A508) | PCR primers with index sequences and |
| sequencing adapters | |
| Index Primers 1 (A701) - 12 (A712) | PCR primers with index sequences and |
| sequencing adapters | |
| PCR Polymerase | Proprietary DNA polymerase |
| PCR Master Mix | Buffered aqueous solution containing salts and |
| dNTPs |
Box 1A Pre-Amp reagents :
Box 1B Post-Amp Reagents
| Component | Active Ingredients |
|---|---|
| Library Normalization | |
| Diluent | Buffered aqueous solution containing salts, 2-Mercaptoethanol, and formamide |
| Library Dilution | |
| Buffer | Buffered aqueous solution |
| PhiX Internal Control | Buffered aqueous solution containing PhiX genomic DNA |
Box 2 Post-Amp Reagents
| Component | Contents |
|---|---|
| MiSeqDx | Single-use cartridge that contains cluster generation and |
| Reagent | sequencing reagents for use with the MiSeqDx, including |
| Cartridge | formamide, 2-Mercaptoethanol, and |