Who is the manufacturer of ANTHOS PHACTS VERSION MICROPLATE READER?

Columbia Bioscience, Inc. filed the 510(k) submission for ANTHOS PHACTS VERSION MICROPLATE READER (K962113).

What is the FDA product code for ANTHOS PHACTS VERSION MICROPLATE READER?

JJQ. It is classified under 21 CFR 862.2300 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for ANTHOS PHACTS VERSION MICROPLATE READER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ANTHOS PHACTS VERSION MICROPLATE READER?

Anthos 2001 Microplate Reader (K894270); Anthos ht2 Microplate Reader (K931907); Anthos 2010 Microplate Reader (K955077).

Who can help prepare an FDA 510(k) submission like ANTHOS PHACTS VERSION MICROPLATE READER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ANTHOS PHACTS VERSION MICROPLATE READER

K962113 · Columbia Bioscience, Inc. · JJQ · Nov 5, 1996 · Clinical Chemistry

Device Facts

Record ID	K962113
Device Name	ANTHOS PHACTS VERSION MICROPLATE READER
Applicant	Columbia Bioscience, Inc.
Product Code	JJQ · Clinical Chemistry
Decision Date	Nov 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2300
Device Class	Class 1

Intended Use

The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.

Device Story

Device: microplate photometer; clinical laboratory use. Input: light from tungsten halogen lamp focused on microtiter plate wells. Operation: silicon-photodiodes measure light absorbance of samples; data reduction software processes absorbance values. Output: qualitative or quantitative assay results. Usage: clinical laboratory personnel; automated transport mechanism positions wells. Benefit: enables automated, standardized photometric analysis of clinical assays.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical and functional comparison to predicate devices.

Technological Characteristics

Photometric microplate reader; tungsten halogen lamp light source; silicon-photodiode detectors; automatic well transport mechanism. Data reduction software for absorbance calculation.

Indications for Use

Indicated for use as a general purpose microplate photometer in clinical settings for measuring light absorbance in microtiter plate wells to yield qualitative or quantitative assay results.

Regulatory Classification

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.

Predicate Devices

Anthos 2001 Microplate Reader (K894270)
Anthos ht2 Microplate Reader (K931907)
Anthos 2010 Microplate Reader (K955077)

Related Devices

K961183 — CBI 7520 READER · Columbia Bioscience, Inc. · Aug 2, 1996
K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER · Sfri, Inc. · Feb 4, 1998
K962265 — MLX MICROTITER PLATE LUMINOMETER · Dynatech Laboratories, Inc. · Jul 25, 1996
K103532 — AUTOREADER 2 · Trek Diagnostic Systems · Aug 26, 2011
K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER · Digene Corp. · Feb 6, 1998

Submission Summary (Full Text)

{0} K962113 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 Contact: Norman Jenkins 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.