← Product Code [JIL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL) · K120124

# FORESIGHT U120 URINE ANALYZER (K120124)

_ACON Laboratories, Inc. · JIL · Mar 6, 2012 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K120124

## Device Facts

- **Applicant:** ACON Laboratories, Inc.
- **Product Code:** [JIL](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL.md)
- **Decision Date:** Mar 6, 2012
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 862.1340
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Foresight™ U120 Urine Analyzer is intended for use in conjunction with the Foresight Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, pH, Blood, Protein, Urobilinogen, Leukocytes and Ascorbic Acid as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract.

## Device Story

Foresight™ U120 Urine Analyzer (formerly ACON™ U120); semi-quantitative urine analyte determination; clinical laboratory use. Modification includes external housing redesign; altered dimensions; relocated external printer to rear; repositioned test strip tray under keypad. Fundamental scientific technology remains unchanged from predicate. Device processes urine test strips; provides semi-quantitative results for clinical decision-making.

## Clinical Evidence

No clinical data; bench testing only. Substantial equivalence supported by design control activities, risk analysis, and verification of physical modifications.

## Technological Characteristics

Reflectance photometry-based urine analyzer. Measures color intensity of reagent strips via optical sensors. Standalone benchtop instrument. Software-controlled processing of optical data. Designed for professional use.

## Regulatory Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

## Predicate Devices

- ACON™ U120 Urine Analyzer ([K070929](/device/K070929.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K120124

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. ACON™ U120 Urine Analyzer k070929
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for

- External changes to instrument housing –
- Change in housing dimensions
- External printer moved to rear of instrument
- Test strip tray moved to fit under instrument keypad
- Change in instrument name from ACON™ U120 Urine Analyzer to the Foresight™ U120 Urine Analyzer

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K120124](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIL/K120124)

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