Who is the manufacturer of CBI 7520 READER?

Columbia Bioscience, Inc. filed the 510(k) submission for CBI 7520 READER (K961183).

What is the FDA product code for CBI 7520 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 CBI 7520 READER?

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

What are the predicate devices for CBI 7520 READER?

Anthos 2001 Microplate Reader (K894270); Anthos ht2 Microplate Reader (K931907); Anthos 2010 Microplate Reader (K9xxxxx).

Who can help prepare an FDA 510(k) submission like CBI 7520 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.

CBI 7520 READER

K961183 · Columbia Bioscience, Inc. · JJQ · Aug 2, 1996 · Clinical Chemistry

Device Facts

Record ID	K961183
Device Name	CBI 7520 READER
Applicant	Columbia Bioscience, Inc.
Product Code	JJQ · Clinical Chemistry
Decision Date	Aug 2, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2300
Device Class	Class 1

Intended Use

The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.

Device Story

CBI 7520 Microplate Reader; general purpose photometer for clinical laboratory use. Input: light transmitted through microtiter plate wells. Operation: Tungsten halogen lamp light source; silicon-photodiode sensors measure light absorbance per well; automatic transport mechanism positions wells. Output: absorbance values processed by software to yield qualitative or quantitative assay results. Used in clinical settings by laboratory personnel. Benefits: enables automated, high-throughput measurement of clinical assays.

Clinical Evidence

Bench testing only; no clinical data presented. Equivalence established via comparison of technical characteristics and principles of operation.

Technological Characteristics

Tungsten halogen lamp light source; silicon-photodiode detectors; automatic microplate transport mechanism. Standalone benchtop photometer. Data reduction software performs absorbance calculations.

Indications for Use

Indicated for clinical use as a general purpose microplate photometer for measuring light absorbance in microtiter plate wells.

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 (K9xxxxx)

Related Devices

K962113 — ANTHOS PHACTS VERSION MICROPLATE READER · Columbia Bioscience, Inc. · Nov 5, 1996
K973938 — ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER · Sfri, Inc. · Feb 4, 1998
K103532 — AUTOREADER 2 · Trek Diagnostic Systems · Aug 26, 2011
K980120 — DIGENE DML 2000 MICROPLATE LUMINOMETER · Digene Corp. · Feb 6, 1998
K962265 — MLX MICROTITER PLATE LUMINOMETER · Dynatech Laboratories, Inc. · Jul 25, 1996

Submission Summary (Full Text)

{0} K961183 AUG - 2 1996 Attachment 7 # 510(K) SUMMARY ## CBI 7520 Microplate Reader ### Submitter's Name, Address, Telephone and 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} 15 # 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 yield a specific well absorbance value which in turn can yield 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 operation for its indications for use as the predicate devices.