(158 days)
Not Found
No
The description focuses on standard photometric principles and data reduction software, with no mention of AI or ML terms or concepts.
No
The device is described as a "general purpose microplate photometer for clinical use" that measures light absorption to yield a qualitative or quantitative assay result, indicating it is for diagnostic or analytical purposes, not for treating a disease or condition.
Yes
The device measures properties of a sample (light absorbed) to yield a qualitative or quantitative assay result, which is indicative of a diagnostic purpose. The Intended Use also states "general purpose microplate photometer for clinical use."
No
The device description clearly outlines hardware components (light source, silicon-photodiodes) that are integral to the device's function, in addition to the data reduction software.
Yes, based on the provided information, the Anthos PhACTS 2010 Microplate Reader is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "clinical use" and is a "general purpose microplate photometer". Microplate readers are commonly used in clinical laboratories to perform various in vitro diagnostic tests (e.g., ELISA, enzyme assays) on patient samples (like blood, urine, etc.).
- Device Description: The description details how the device measures light absorbance in microplate wells, which is a fundamental principle used in many in vitro diagnostic assays to quantify or qualify substances in a sample. The mention of "qualitative or quantitative assay result" further supports its use in diagnostic testing.
- Predicate Devices: The listed predicate devices are also microplate readers, which are typically classified as IVDs.
While the document doesn't provide details about specific assays or patient populations, the core function and intended use clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
Product codes
Not Found
Device Description
Not Found
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Attachment 7
510(K) SUMMARY
NOV - 5 1996
ANTHOS PHACTS VERSION MICROPLATE READER
1
Attachment 7
510(K) SUMMARY
Anthos PhACTS Version Microplate Reader
Submitter's Name, Address, Telephone Number, And Contact Person
Columbia Bioscience, Inc.
182 Thomas Johnson Dr., Suite 205 Frederick, MD 21702
Norman Jenkins Contact: President Columbia Bioscience, Inc.
Tel. (301) 696-8520
Fax: (410) 995-0508
Name of the Device
Anthos PhACTS Version 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 (K955077);
Intended Use
The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
2
Principles of Operation
The Anthos PhACTS 2010, 2001 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 yield a specific well absorbance value which in turn can yield a qualitative or quantitative assay result.. Thus, the Anthos PhACTS 2010, 2001 and its predicate devices have similar principles of operation.
Technical Characteristics
The Anthos PhACTS 2010 and 2001 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 Anthos PhACTS version readers use the same technique for the measurement of light absorbance and are equivalent to the predicate devices for its intended use. There is no substantial difference between the Anthos PhACTS version readers and their predicate devices in performance or technical characteristics. The Anthos PhACTS readers have the same intended use, indications for use, and the same principles of operation for its indications for use as the predicate devices.