PERSONALLAB AUTOMATED MICROPLATE ANALYZER

K971761 · Biochem Immunosystems (U.S.), Inc. · JJE · Jul 22, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971761
• Device Name: PERSONALLAB AUTOMATED MICROPLATE ANALYZER
• Applicant: Biochem Immunosystems (U.S.), Inc.
• Product Code: JJE · Clinical Chemistry
• Decision Date: Jul 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2160
• Device Class: Class 1

Intended Use

The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as: - E.I.A. (Enzyme Immuno Assay), and - E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows: - Specimen handling and identification, - Specimen pipetting and pre-dilution, - Reagent distribution and pipetting. - Washing of the microplates. - Incubation of the microplates, - Photometric reading of the microplates, - Data analysis -- both quantitative and qualitative, - Data management - displaying, printing and archiving, and - Waste management. The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows: - Whole blood, - Serum. - Plasma. - Urine, - Stool. - Spinal fluid, - Saliva, and - Swabs from antigen sites.

Device Story

PersonalLAB™ is a fully automated microplate analyzer designed to replicate manual laboratory procedures for EIA and ELISA assays. Input: human/animal specimens (blood, serum, plasma, urine, stool, spinal fluid, saliva, swabs) and assay reagents. Operation: system performs automated specimen handling/identification, pipetting, pre-dilution, reagent distribution, microplate washing, incubation, and photometric reading. Output: quantitative and qualitative data analysis, display, printing, and archiving of results. Used in clinical laboratory settings by trained personnel. Automates repetitive manual tasks to improve throughput and consistency in diagnostic testing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Automated microplate analyzer for 96-well formats. Features include robotic specimen/reagent pipetting, integrated washing, incubation, and photometric reader. System manages waste and data processing. Designed for in vitro diagnostic use.

Indications for Use

Indicated for in vitro diagnostic processing of human and animal specimens (whole blood, serum, plasma, urine, stool, spinal fluid, saliva, swabs) using 96-well microplate-based EIA and ELISA techniques.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 1997

Mr. James SaFranko · Manager, Quality Assurance and Regulatory Affairs BioChem ImmunoSystems, Inc............................... 100 Cascade Drive Allentown, PA 18103-9562

Re : K971761 PersonalLAB™ Automated Microplate Analyzer Regulatory Class: I Product Code: JJE Dated: May 9, 1997 Received: May 12, 1997

Dear Mr. SaFranko:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Sitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

## Device Name: PersonalLAB™ Automated Microplate Analyzer

## Indications For Use:

The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as:

- E.I.A. (Enzyme Immuno Assay), and ●
- E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). ●

The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows:

- Specimen handling and identification, ●
- Specimen pipetting and pre-dilution, .
- Reagent distribution and pipetting. .
- Washing of the microplates. .
- Incubation of the microplates, .
- Photometric reading of the microplates, .
- Data analysis -- both quantitative and qualitative, .
- . Data management - displaying, printing and archiving, and
- Waste management. .

The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows:

- Whole blood, ●
- Serum. .
- . Plasma.
- Urine, .
- Stool. .
- Spinal fluid, .
- . Saliva, and
- Swabs from antigen sites. ●

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------------------|---------|
| Division of General Laboratory Devices | |
| 510(k) Number | k971761 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)April 20, 1997

Exhibit 8

DAMA