(81 days)
No
The description focuses on standard automated laboratory procedures and does not mention any AI/ML components or capabilities.
No
The device is described as an "in vitro diagnostic analyzer," which means it is used to analyze samples outside of the body for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that it is "an in vitro diagnostic analyzer."
No
The device description explicitly details hardware components and functions, such as sample measurement, pipetting, incubation, shaking, aspiration, washing, and photometric measurement. This indicates it is a physical instrument, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures."
The "Device Description" section also reiterates this: "The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures."
These statements clearly indicate that the device is designed to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures. The instrument performs initial sample measurement and pipetting, timed addition of assay reagents, incubation and shaking of assay tubes, aspiration of used reagents and washing of coated polystyrene assay beads and photometric measurement of the chromogen / enzyme reaction.
Product codes
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Device Description
The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures. The instrument performs initial sample measurement and pipetting, timed addition of assay reagents, incubation and shaking of assay tubes, aspiration of used reagents and washing of coated polystyrene assay beads and photometric measurement of the chromogen / enzyme reaction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
To demonstrate equivalence in performance characteristics, three representative assays were evaluated for precision and accuracy: COBAS Core LH, COBAS Core FSH, and COBAS Core Ferritin.
Precision Study: Four internal reference sera and the kit control were tested to evaluate the within-run and run-to-run reproducibility of the COBAS Core II analyzer. For within-run precision, samples were tested seven times in triplicate. For run-to-run precision, the same samples were tested in duplicate in 10 independent runs. Except for one serum with a very low LH level, all CV's were far below 10%. The precision range found for the COBAS Core II corresponded to the values determined for the COBAS Core I.
Correlation Study: The correlation of the COBAS Core I and COBAS Core II was evaluated using 137 randomly selected clinical samples run in duplicate on both analyzers. The results of Core I and Core II were compared using linear regression analysis. For all three assays, the calculated slopes were 1.000 ± 0.014 with a correlation coefficient > 0.995.
Key Metrics
For the correlation study, calculated slopes were 1.000 ± 0.014 with a correlation coefficient > 0.995 for all three assays.
For within-run and run-to-run precision, except for one serum with a very low LH level, all CV's were far below 10%.
Predicate Device(s)
Reference Device(s)
K920829, K930776, K930305, K932605, K930304, K932608, K930306, K932607, K930890, K942676
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for Roche Diagnostic Systems. The Roche logo is a stylized hexagon with the word "Roche" inside. The text "Roche Diagnostic Systems" is written in a bold, sans-serif font to the right of the logo. The logo and text are black against a white background.
A Member of the Roche Group
AUG 30 1996
Roche Diagnostic Systems, Inc Branchburg Township 1080 U S. Highway 202 Somerwile, New Jersey 08876-3771
Direct Dial F : x
510(k) Summary
Roche COBAS Core II Immunochemistry System
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary as outlined in 21 CFR 807.92 is provided herewith.
I. Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roched, Inc. Branchburg Township 1080 US Highway 202 Somerville, NJ 08876-3771
510(k) Submission dated June 7, 1996
II. Description of the Device/Statement of Intended Use:
The COBAS Core II Immunochemistry System is an in vitro diagnostic analyzer intended for enzymeimmunoassay procedures. The instrument performs initial sample measurement and pipetting, timed addition of assay reagents, incubation and shaking of assay tubes, aspiration of used reagents and washing of coated polystyrene assay beads and photometric measurement of the chromogen / enzyme reaction.
III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:
The COBAS Core II Immunochemistry System is substantially equivalent to the currently marketed Roche COBAS Core Immunochemistry System (K921180).
1
Summary of the technological characteristics of the new device in IV. comparison to those of the predicate.
Similarities to predicate
- Both instruments are intended for automation of the currently marketed Roche COBAS . Core assays:
| COBAS Core Ferritin (K920829) | COBAS Core TSH (K930776) |
|---|---|
| COBAS Core Prolatin (K930305) | COBAS Core T4 (K932605) |
| COBAS Core FSH (K930304) | COBAS Core T3 (K932608) |
| COBAS Core LH (K930306) | COBAS Core Free T4 (K932607) |
| COBAS Core IgE (K930890) | COBAS Core Free T3 (K942676) |
- Both instruments perform the same basic operations, which are, sample handling, ● pipetting, dilution, incubation, bead washing, measurement and data management.
- Both instruments utilize the coated bead technology and photometric measurement. ●
Differences to predicate device
The differences in the above mentioned devices consist hardware and software changes in the following areas:
| Area of Change | COBAS Core I | COBAS Core II |
|---|---|---|
| Barcode Reader | Infra Red Reader | Laser Barcode Scanner |
| Rack Platform | 6 positions for samples and | |
| reagents | 14 positions for samples and | |
| reagents | ||
| Test /Sample Racks | ||
| Identity | Binary Rack Coding | Barcode Label ID |
| Rack Locking Device | Racks could be unlocked | |
| during processing | Racks are mechanically locked | |
| when in use | ||
| Pipetting Syringes | Module on left side of | |
| instrument | Module moved to the right side of | |
| the instrument with no | ||
| modification to the tube length or | ||
| syringes | ||
| Operating Software | Internally developed | |
| software | Internally developed software | |
| embedded in Microsoft Windows | ||
| NT | ||
| Microprocessor | CPU 186 | PC- 486 DX33 |
| Real Time CPU 186 | ||
| Hard Disk - 350 MB | ||
| RAM - 16 MB | ||
| Diskette - 1.44 MB floppy disk | ||
| drive 3.5" |
2
Breif discussion of the clinical and nonclinical tests relied on for a V . determination of substantial equivalence:
To demonstrate equivalence in performance characteristics, three representative assays were evaluated for precision and accuracy. The three assays are: COBAS Core LH COBAS Core FSH COBAS Core Ferritin
Precision Study
Four internal reference sera and the kit control were tested to evaluate the within-run and run-to-run reproducibility of the COBAS Core II analyzer. For within-run precision the samples were tested seven times in triplicate. For the run-to run precision the same samples were tested in duplicate in 10 independent runs. Except for one serum with a very low LH level, all CV's are far below 10%. The precision range found for the COBAS Core II correspond to the values determined for the COBAS Core I.
Correlation Study
The correlation of the COBAS Core I and COBAS Core II was evaluated using 137 randomly selected clinical samples run in duplicate on both analyzers. The results of Core I and Core II were compared using linear regression analysis. For all three assays, the calculated slopes were 1.000 ± 0.014 with a correlation coefficient > 0.995.