{
  "format": "devicerts.device.v1",
  "cite_as": "One Step Pregnancy Test, Spd Swiss Precision Diagnostics GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/one-step-pregnancy-test-lcx (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/one-step-pregnancy-test-lcx",
    "json_url": "https://devicerts.com/devices/one-step-pregnancy-test-lcx.json",
    "markdown_url": "https://devicerts.com/devices/one-step-pregnancy-test-lcx.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/one-step-pregnancy-test-lcx",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "One Step Pregnancy Test",
    "registry_name": "One Step Pregnancy Test",
    "url": "https://devicerts.com/devices/one-step-pregnancy-test-lcx",
    "manufacturer": {
      "name": "Spd Swiss Precision Diagnostics GmbH",
      "url": "https://devicerts.com/manufacturers/fda-fei-3006635320",
      "country": "Switzerland",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K210341",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "LCX"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The One Step Pregnancy Test is a Pregnancy Test Kit designed to detect human chorionic gonadotropin (hCG) in urine, indicating pregnancy. It provides a qualitative result within minutes, allowing for early confirmation of pregnancy through a simple, over-the-counter diagnostic process. The device is classified as a Class II medical device under FDA regulations, adhering to standards for diagnostic accuracy and reliability.\n\nThis test is intended for home use and requires no professional interpretation. Supplied as a single-use, non-sterile device, it includes all necessary components for a one-step urine collection and result interpretation. The test is approved for FDA 510(k) clearance under the Clinical Chemistry advisory committee and is distributed under the product code LCX. Storage instructions and expiration dates are specified on the packaging, ensuring proper handling before use.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K210341",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-03-10",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
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            {
              "value": "K210341",
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            }
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            }
          ]
        },
        {
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            {
              "value": "21 CFR Part 862.1155",
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            }
          ]
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              "value": "Clinical Chemistry",
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}