(129 days)
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No
The summary describes a standard microplate reader with mechanical and optical components, and there is no mention of AI, ML, or related concepts.
No.
The device is a microplate reader for clinical use, measuring light absorbance for diagnostic purposes, rather than directly treating a disease or condition.
No
Explanation: The device is described as a "general purpose microplate photometer for clinical use," which suggests laboratory equipment for analysis rather than directly diagnosing a patient's condition. It measures light absorbance, a common function in laboratory assays, but does not perform diagnostic interpretation itself.
No
The device description explicitly details hardware components such as an automatic transport mechanism, Tungsten halogen lamp, and silicon-photodiodes, indicating it is a physical device, not software-only.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the device is "intended to be used as a general purpose microplate photometer for clinical use." This indicates that the device is used to perform tests on samples derived from the human body for the purpose of providing information for clinical diagnosis, treatment, or prevention of disease.
- Device Description: The description of the device as a "microplate reader" that measures "light absorbance" is consistent with the technology used in many IVD assays performed in microplates (e.g., ELISA, photometric assays).
- Intended User / Care Setting: The mention of "clinical use" further supports its role in a healthcare setting where IVD testing is performed.
- Predicate Devices: The listed predicate devices are also microplate readers, which are commonly used in IVD applications.
Therefore, the CBI 7520 Microplate Reader, as described, fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
Product codes
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Device Description
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
(a)
Identification. A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.(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
AUG - 2 1996
Attachment 7
510(K) SUMMARY
CBI 7520 Microplate Reader
Submitter's Name, Address, Telephoneand Fax Number, And Contact Person
Columbia Bioscience, Inc. 182 Thomas Johnson Drive Suite 205 Frederick, Maryland 21702
- Contact: Norman Jenkins Columbia Bioscience, Inc. 182 Thomas Johnson Drive Suite 205 Frederick, Maryland 21702
- Phone: (301) 941-7971
Facsimile: (410) 995-0508
Name of the Device
CBI 7520 Microplate Reader
Common or Usual Name
Microplate reader
Predicate Devices
- (1) Anthos 2001 Microplate Reader (K894270);
- (2) Anthos ht2 Microplate Reader (K931907)
- (3) Anthos 2010 Microplate Reader (K9xxxxx);
1
Intended Use
The CBI 7520 Microplate Reader is intended to be used as a
general purpose microplate photometer for clinical use.
Principles of Operation
The CBI 7520 and its predicate devices all share the same principle of operation. Briefly, each device provides a light source which is focused to provide illumination of wells in a microtiter plate. A corresponding silicon-photodiodes measures the amount of light absorbed by the sample as the light passes through the microplate well. The respective well absorbance measurements is used by the data reduction software to vield a specific well absorbance value which in turn can vield a qualitative or quantitative assay result .. Thus, the CBI 7520 and its predicate devices have similar principles of operation.
Technical Characteristics
The CBI 7520 microplate reader and the predicate readers employ an automatic transport mechanism to bring the individual microplate wells into position for reading. The devices all employ Tungsten halogen lamp as the light source. All three devices use silicon-photodiodes to measure the light absorbance.
Summary of the Basis for the Finding of Substantial Equivalence
The CBI 7520 for the measurement of light absorbance is equivalent to the predicate devices for its intended use. There is no substantial difference between the CBI 7520 and its predicate devices in performance or technical characteristics. The CBI 7520 has the same intended use, indications for use, and the same principles of overation for its indications for use as the predicate devices.