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510(k) Data Aggregation
(57 days)
NANOGEN, INC.
The Real-Time PCR Internal Control 2B Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control 2B Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
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The provided document is a 510(k) premarket notification letter from the FDA to Nanogen, Inc. regarding their Real-Time PCR Internal Control 2B Set. This document does not contain information about acceptance criteria, study details, or performance data of the device.
The letter states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other requirements under the Federal Food, Drug, and Cosmetic Act. The "Indication for Use" section describes the intended purpose of the device as an unassayed internal extraction and amplification process control in real-time PCR assays.
Since the provided text is a regulatory clearance letter and not a study report or a detailed submission, it lacks the specific information requested in your prompt regarding acceptance criteria and device performance studies. Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or multi-reader studies.
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(270 days)
NANOGEN, INC.
StatusFirst™ CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.
The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.
The provided document describes a 510(k) premarket submission for the StatusFirst™ CHF NT-proBNP device, which measures NT-proBNP levels for aid in CHF diagnosis. The study described is a method comparison study intended to demonstrate substantial equivalence to a predicate device, the Roche Elecsys® proBNP Immunoassay.
Here's an analysis of the provided information according to your requested categories:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents the results of a method comparison study against a predicate device, aiming to demonstrate substantial equivalence. The "reported device performance" is primarily shown through the correlation between the StatusFirst™ device and the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (StatusFirst™ CHF NT-proBNP vs. Elecsys® proBNP) |
|---|---|
| Good correlation for CHF subjects (compared to predicate) | Spearman Rank correlation: 0.922 (n = 324) |
| Good correlation for non-CHF subjects (compared to predicate) | Spearman Rank correlation: 0.948 (n = 324) |
| Good correlation for all subjects combined (compared to predicate) | Spearman Rank correlation: 0.973 (n = 648) |
| Agreement in measuring range (though predicate has wider range, the functional range of the new device should be clinically useful and comparable) | StatusFirst™ Measuring Range: 20-5,000 pg/mL |
| Elecsys® proBNP Measuring Range: 5-35,000 pg/mL (StatusFirst™ falls within a relevant clinical range) | |
| Functional Sensitivity (comparable to predicate) | StatusFirst™ Functional Sensitivity: 20 pg/mL |
| Elecsys® proBNP Functional Sensitivity: |
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